FDA's OLP product code — Over-The-Counter Powered Light Based Laser For Acne — is the classification that covers light-based acne devices. Led Technologies Inc., the manufacturer behind the Dr. Dennis Gross DRx hardware, holds two related 510(k)s under it. Neither can be confidently matched to the retail device: the GUDID record for the mask actually sold shows its own submission number withheld, not either of those two K-numbers. That gap — a real device, a real manufacturer clearance history, no confirmable link between them — turns out to be the pattern here, not the exception. Only two masks in our whole catalog carry the blue wavelength this indication needs in the first place, and neither has a clearance record we could confirm for it.
Check This Yourself
Search by device name and by manufacturer at accessdata.fda.gov and AccessGUDID — a missing result under the retail name alone doesn't settle anything. Full search log on our clearance check page.
A blue-light LED mask might help if…
- Your acne is mild to moderate — scattered breakouts, not widespread cystic lesions
- You want an at-home adjunct alongside a skincare routine, not a stand-alone treatment
- You're comfortable that neither device below has a confirmed FDA record for this specific use
- Consistency over months matters more to you than a fast result
- You've already ruled out a photosensitizing medication or condition (see the safety guide below)
See a dermatologist instead if…
- Your acne is moderate to severe, cystic, or leaving scarring
- It's hormonal and hasn't responded to topical treatment
- You've tried consistent at-home care for months without improvement
- You want a treatment with clinical evidence behind it for your specific case
- You want a prescription option — topical or oral — not an over-the-counter device
Quick Picks
Flip side: on our anti-aging page, this same device IS flagged "not recommended" — same unmatched-record status either way, but there it's competing against four well-differentiated masks instead of exactly one other unconfirmed candidate. The field changes; the registry status doesn't.
- 3-minute sessions — the shortest published in this catalog
- Red (630nm) and blue (415nm) light in one device, combined mode selectable
- Rigid shell sits off the face — no direct skin contact
- FSA/HSA eligible in the US
- Tethered to a controller — not wireless
- No near-infrared wavelength
- FDA record exists for the manufacturer's device line but can't be matched to this specific product
- 360 LEDs — the highest published count in this catalog
- Only mask here combining red, near-infrared, and blue wavelengths
- Lowest price tier in this catalog
- Not wireless — tethered to a controller cable
- No FDA record found under this device name in any of the three databases we checked
- Product listing displays an uncredited "FDA Cleared Technology" icon with no clearance number attached
Head-to-Head Comparison
| Feature | Dr. Dennis Gross DRx | iRestore Illumina |
|---|---|---|
| Wavelengths | 630 / 415nm | 635 / 830 / 415nm |
| LED count | 162 (100 red + 62 blue) | 360 |
| Wireless | No — tethered | No — tethered |
| Session length | 3 minutes | Not published |
| Price tier | $$ | $ |
| FDA status | Unmatched records | No record found |
| FDA-adjacent marketing claim on listing | None found | Uncredited "Cleared Technology" icon, no number |
How to Choose
Want the shortest, most repeatable routine? Dr. Dennis Gross DRx runs 3-minute sessions with a combined red+blue mode. Check price on Amazon ↗(paid link)
Want more wavelength types and a lower price, and you're not bothered by an unverified claim on the listing? iRestore Illumina adds near-infrared and costs less — see the marketing-claim row above before you decide that doesn't matter to you. Check price on Amazon ↗(paid link)
Want a device with a confirmed FDA record specifically for acne? Neither device in this catalog has one today. Check any device yourself against the FDA's 510(k) database before buying — see "Check This Yourself" above.
Don't Buy One of These If
- ✗ Your acne is moderate to severe or cystic → a dermatologist — prescription treatment is a different category than an at-home LED device
- ✗ Your acne is hormonal and hasn't responded to topical treatment → a dermatologist or your doctor, not a light-therapy device
- ✗ You're expecting a visible change within a week → don't buy yet — this is a slow, cumulative-use category, not a quick fix
- ✗ You're not ready to use one on bare, clean skin several times a week for months → don't buy one you won't stick with
- ✗ You need a device with a confirmed FDA clearance specifically for acne → neither device here has one — verify any device yourself via the FDA 510(k) database first
- ✗ You're pregnant, on a photosensitizing medication (e.g. isotretinoin), or have an active skin infection → talk to your doctor before using any LED device, not just before buying one
Frequently Asked Questions
Does either device have an FDA clearance specifically for acne?
Not one we could confirm. Dr. Dennis Gross DRx's registry status is records exist, device cannot be matched — the manufacturer has clearance history but no record ties it to this exact product. iRestore Illumina's status is no record found under this device name in any of the three databases we searched. See our full clearance check for both search logs.
What does the OLP product code mean, and why does it matter here?
"Over-The-Counter Powered Light Based Laser For Acne" — the FDA classification behind two 510(k)s the DRx hardware's manufacturer, Led Technologies Inc., holds: K171386 and K183247. Neither is referenced by the retail device's own GUDID record, which lists its submission number as withheld. Same manufacturer, no confirmed device-to-record match — so we don't attribute either K-number to this product.
Is iRestore's "Cleared Technology" icon an FDA clearance?
We can't confirm that from the databases. The product page carries a circular seal reading "Cleared Technology," styled to match adjacent IEC and ISO seals and labelled "Icon for FDA Cleared Technology" in the page source — but no clearance number appears alongside it, and our search of all three FDA/NLM databases returned no record under the device name Illumina.
Should I just avoid LED light therapy for acne entirely?
That's not what this page establishes. We're reporting what the registries show for two specific retail devices, not a verdict on light therapy as a category. If an FDA record confirmed specifically for acne matters to your decision, neither device here provides one today — verify any device yourself before buying rather than taking a listing's word for it.
Why is Dr. Dennis Gross ranked ahead of iRestore if neither has a confirmed FDA record?
Both carry the same kind of registry gap, so FDA status doesn't separate them. What does: iRestore's own listing displays an FDA-adjacent seal with no clearance number behind it, which Dr. Dennis Gross's listing does not do. That's the basis for the ranking below, not a claim that one treats acne better than the other.
Advertising Disclosure
This page contains Amazon affiliate links, each marked (paid link). LED Mask Lab is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by linking to Amazon.com. We don't accept payment for placement, and commissions do not influence rankings or FDA-status reporting on this page.