NEWKEY vs CurrentBody: An Honest Comparison of Two FDA-Cleared LED Masks

We sell the NEWKEY mask, so the ground rules stay the same as in our NEWKEY vs Omnilux comparison: every regulatory claim on both sides is checked against the FDA's own 510(k) database, the sections where CurrentBody beats us are stated first and in full, and we link the primary sources so you can verify rather than trust. CurrentBody's Series 2 is the best-marketed LED mask in the world — that sentence is not flattery, it is context for a price gap you deserve to understand before paying it.

Vocabulary check first, as always: both masks discussed here are FDA-cleared, and neither is FDA-approved. Clearance under 510(k) means the FDA found the device substantially equivalent to a legally marketed predicate — it is a safety-and-equivalence review, not a clinical-trial proof. No consumer LED mask on the market has PMA approval, whoever is selling it.

The one-paragraph verdict

The CurrentBody Series 2 is the more ambitious anti-ageing device: it adds a 1072nm deep near-infrared channel that almost nothing else in the category has, it is wireless and flexible, and it is backed by an actual published clinical trial. It costs $469.99 — 2.8 times our price. The NEWKEY mask is the only one of the two cleared to treat acne: the Series 2 emits no blue light and carries no acne indication at all. If you want the deepest-reaching anti-ageing hardware and money is secondary, buy CurrentBody. If you are treating breakouts alongside fine lines, or $469 is not a casual number, the NEWKEY mask is the rational choice — and the rest of this article is the receipts.

Side by side: the verified specifications

	NEWKEY 4D Mask	CurrentBody Series 2
Price	$169.99	$469.99 (US MSRP)
FDA clearance	Cleared May 5, 2023	Cleared June 25, 2025
Cleared indications	Full-face wrinkles and mild-to-moderate inflammatory acne	Wrinkles / anti-ageing only
Wavelengths	Red 650nm, Blue 465nm	Red 633nm, NIR 830nm, Deep NIR 1072nm
LED count	150 LEDs / 450 light-emitting chips (manufacturer-stated)	236 LEDs (110 red + 110 NIR + 16 deep NIR)
Irradiance	Up to 75 mW/cm² (manufacturer-stated, not independently verified)	30 mW/cm² claimed; 18.5 mW/cm² in independent measurement
Form factor	Rigid 4D-contour shell, corded	Flexible silicone, wireless, USB-C, chin strap
Session	10 minutes, auto shut-off, 3–5×/week	10 minutes, 3–5×/week, one preset
Money-back window	90 days, full refund	60 days, minus 10% restocking fee
Warranty	2 years (manufacturing defects and component failure)	2 years (full refund first 6 months; store credit or exchange after)
Reviews	4.8/5, smaller base	4.6/5, 4,000+ on-site reviews

Two rows need the same honesty we applied in the Omnilux article. Our irradiance figure comes from our own documentation with no third-party verification yet; CurrentBody's claimed 30 mW/cm² has been measured at 18.5 by independent reviewers. And the LED counts use different units — 236 counts their LED packages, our 450 counts three emitter chips per package. Neither number is a lie; comparing them naively flatters somebody.

Where CurrentBody genuinely wins

1. The 1072nm deep near-infrared channel

Sixteen of the Series 2's 236 LEDs emit at 1072nm, which penetrates deeper than the 830nm band that most premium masks (including Omnilux) treat as their ceiling. CurrentBody cites early research on this range for deep wrinkle treatment, and no NEWKEY device — face or neck — emits anywhere near it. If "deepest-reaching wavelength available in a consumer mask" is the specification you care about most, the Series 2 is currently the mainstream answer, and the premium is partly buying exactly that.

2. A real clinical trial, with the instrumentation to show

This is the strongest card CurrentBody holds and we are not going to minimize it: an SGS-conducted, 56-day, single-centre trial on 35 subjects using VISIA-CR imaging, 3D wrinkle mapping, corneometer, cutometer and expert clinical grading, reporting around 30% wrinkle-volume reduction and 57% elasticity improvement, statistically significant at day 56. That is far more efficacy evidence than a standard 510(k) requires and more than we have published. Our cleared-device claim rests on safety testing and substantial equivalence; theirs adds a funded trial. If you want published numbers behind the box, CurrentBody has them and we do not.

3. Comfort, fit and freedom of movement

The Series 2 is a flexible liquid-silicone shell with a chin strap for jawline coverage, a clip-on controller, and USB-C charging — ten untethered minutes per session. Ours is a rigid contour that plugs into the wall. The rigid-vs-flexible debate has an optical argument each way, but the habit argument is not close: the device you can wear while reading is the device you will still be wearing in week nine. CurrentBody's chin strap also covers an area our 4D contour does not.

4. Scale, track record and per-unit transparency

CurrentBody markets the Series line as the world's bestselling LED mask, shows 4,000+ on-site reviews averaging 4.6, and has collected more 2025 beauty awards than we can fit in a paragraph. Its Veritace system attaches an NFC card to each mask documenting that unit's quality testing. Our review base is two orders of magnitude smaller. Survival data at scale is a legitimate reason to pay more, and we would rather say so than pretend it isn't.

Where the NEWKEY mask genuinely wins

1. The acne indication — still the deciding fact

Our FDA clearance covers two indications: full-face wrinkles via red 650nm and mild-to-moderate inflammatory acne via blue 465nm. The Series 2 emits no blue light and holds a single cleared indication — wrinkle treatment. CurrentBody sells separate blue-light masks, but the flagship Series 2 you are comparing against cannot legally address acne. If breakouts are part of your problem list, one device here can treat them and the other cannot.

2. Price, stated plainly

$169.99 against $469.99 is a 64% discount. Over the two-year warranty at four sessions a week, that is roughly $0.41 per session versus $1.13. The premium buys real things — the 1072nm channel, the trial, the comfort — but it also buys marketing, retail operations and an award budget, and you are allowed to decide how much of that you personally need. A wavelength advantage is real; it is not infinitely real.

3. Return terms, in the fine print where they live

Our money-back window is 90 days with a full refund. CurrentBody's headline guarantee is 60 days — but minus a 10% restocking fee, and their standard return policy only covers unused, unopened masks; an opened mask goes through the money-back process, which requires following the recommended protocol and returning every accessory including the Veritace NFC card. Their warranty also shifts after six months: faulty after month six means store credit or exchange, not a refund. Given that photobiomodulation needs 8–12 weeks of consistent use before results are worth judging, a window that expires before the biology does is a structural problem for any brand — including ours at 30 days, which is why ours is 90.

4. The irradiance question, cut both ways

Independent reviewers measured the Series 2 at 18.5 mW/cm² against its claimed 30 — about 62% of the stated figure, though still in the range the photobiomodulation literature associates with benefit at 10-minute sessions. Our stated figure is higher, and it is exactly as unverified: manufacturer-stated, no independent measurement commissioned. We are telling you both directions of this because irradiance numbers in this category deserve skepticism whichever logo is on the box — including ours.

The paperwork, side by side

• NEWKEY: submitted by Shenzhen SUNGPO HI-TECH Electronic Co., Ltd; cleared May 5, 2023; Class II OTC, product codes OHS/OLP, 21 CFR 878.4810; models MZ-01, NEWKEY-01, SP-FM-01; cleared for wrinkles and mild-to-moderate inflammatory acne. Evidence basis: bench testing, biocompatibility (ISO 10993), electrical and photobiological safety (IEC 60601 series, IEC 62471), substantial equivalence. No clinical trials.
• CurrentBody Series 2: cleared June 25, 2025; the device is model MK-90H from Shenzhen Kaiyan Medical Equipment. Cleared indication: wrinkle treatment. The Series 2 launched in September 2024 according to CurrentBody's own comparison page; the clearance is dated June 25, 2025, about nine months later. That ordering is ordinary in this category and is worth understanding rather than reading as a red flag: an LED mask can be lawfully sold without a 510(k) while its marketing stays inside general-wellness bounds, and a clearance obtained later is what licenses medical claims such as “treats wrinkles”. We are not alleging anything improper about CurrentBody's timeline — we have no way to audit what claims were made during those months, and we are not claiming otherwise. Both dates are simply verifiable, and a date is a better input to your decision than either brand's own summary of it.

One detail from that table deserves its own sentence: both devices trace to Shenzhen-based manufacturers. The brand you buy from and the factory that builds the hardware are different companies in this entire category — CurrentBody's, Omnilux's (via Ismart) and ours alike. What actually differs is the testing, the cleared indications and the warranty behind the logo. That is where your comparison attention belongs.

Cost per session

	NEWKEY 4D Mask	CurrentBody Series 2
Price	$169.99	$469.99
Sessions over 2-year warranty (4/week)	~416	~416
Cost per session	~$0.41	~$1.13
Money-back window	90 days, full refund	60 days, minus 10% restocking fee

Value math only works if it prices in what the premium buys. If the 1072nm channel, the published trial and the wireless fit are what keep you using the device, CurrentBody's cost per session is buying the habit, and it is money well spent. If acne is on your list, or the price gap is the difference between buying and not buying, ours is the honest answer.

Who should buy which

Choose the CurrentBody Series 2 if: anti-ageing is your only goal; the 1072nm deep-NIR channel specifically interests you; you want published clinical numbers behind the purchase; wireless and flexible matters; and $469.99 is comfortable. It is the most complete anti-ageing spec sheet in the mainstream category.

Choose the NEWKEY mask if: you are treating acne as well as fine lines (the Series 2 cannot); the price gap matters; you value a 90-day full-refund window that outlasts the 8–12 week results timeline; and a corded 10-minute session fits your routine.

Consider the hybrid path if budget allows: our face mask plus our cordless neck mask (red 650nm + near-infrared 850nm) totals $249.98 — still $220 under one Series 2 — and covers red, blue and a near-infrared band, though with two devices to manage rather than one polished one.

Frequently asked questions

Is the CurrentBody LED mask FDA cleared?

Yes — the Series 2 is cleared by the FDA (June 25, 2025), model MK-90H, manufactured by Shenzhen Kaiyan Medical Equipment. The cleared indication is wrinkle treatment only; it carries no acne indication and emits no blue light. And as with every consumer LED mask, "cleared" is not "approved" — the PMA approval standard does not apply to this category.

Which mask is better for acne?

The NEWKEY mask, and the reason is regulatory, not marketing: blue 465nm acne treatment is part of our FDA clearance. The CurrentBody Series 2 has no blue-light channel and no cleared acne indication — for acne, it is the wrong instrument regardless of price.

Why is the CurrentBody mask so much more expensive?

The premium funds real things: a 1072nm deep-NIR channel, a published 56-day clinical trial, wireless hardware and a global brand operation. Whether those are worth $300 to you depends entirely on whether deep-NIR anti-ageing is your goal and how you weigh published efficacy data. It does not buy a broader cleared indication set — ours covers two conditions, theirs one.

Which mask has the verified output numbers?

Neither, fully. CurrentBody's claimed 30 mW/cm² was measured at 18.5 by independent reviewers; our 75 mW/cm² is manufacturer-stated with no independent verification yet. Both devices have cleared safety testing. Treat every irradiance figure in this category as a claim, not a fact — including the ones on our box.

Which returns policy is more consumer-friendly?

On paper and in practice, ours: 90 days, full refund, no restocking fee. CurrentBody offers 60 days minus a 10% restocking fee, and its standard returns cover unopened masks only, with the money-back path requiring the full protocol and every accessory returned. Their warranty also converts to store credit or exchange after the first six months.

Sources and verification links

• The FDA 510(k) record for our LED Facial Mask — applicant Shenzhen SUNGPO HI-TECH Electronic Co., Ltd, cleared May 5, 2023 — is searchable in the FDA's 510(k) premarket notification database at accessdata.fda.gov.
• CurrentBody Series 2 — LED Light Therapy Mask (Shenzhen Kaiyan Medical Equipment, model MK-90H), cleared June 25, 2025 — searchable in the FDA's 510(k) premarket notification database at accessdata.fda.gov.
• CurrentBody Series 2 product pages (currentbody.com / us.currentbody.com): $469.99, 236 LEDs (110/110/16), 633 + 830 + 1072nm, 30 mW/cm² stated, 60-day money-back minus 10% restocking, 2-year warranty
• SGS 56-day clinical efficacy study, 35 subjects (VISIA-CR, Primos-CR 3D wrinkle mapping, cutometer, corneometer): published in full by CurrentBody
• Independent irradiance measurement of the Series 2 (18.5 mW/cm² vs 30 claimed): lighttherapyiq.com review
• 21 CFR 807.97 — misbranding by reference to premarket notification: the regulation that makes every cleared-device claim in this article enforceable, for both brands

We sell the NEWKEY 4D mask and profit when you buy it. Every FDA database entry cited here is public — check both devices yourself, and hold us to the same standard you hold them.

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CurrentBody and any associated names and marks are the trademarks of their respective owners, used here only to identify the products being compared. NEWKEY is not affiliated with, endorsed by, sponsored by or otherwise connected to CurrentBody. Specifications, prices, warranty and return terms were accurate as of the sources cited above and can change — where a current term matters to your decision, confirm it on the brand's own page before buying.