FDA product code OLP: Over-The-Counter Powered Light Based Laser For Acne
OLP is the FDA product code for over-the-counter powered light based laser for acne. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 51 510(k) submissions under OLP, 12 in the last five years, from 43 different applicants. The average 510(k) review took 181 days (median 159); 116 days on average over the last three years. FDA has posted 4 recalls for OLP devices.
Definition
The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.
Classification
| Field | Value |
|---|---|
| Device name | Over-The-Counter Powered Light Based Laser For Acne |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for OLP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 220 |
| 2018 | 5 | 135 |
| 2019 | 2 | 175 |
| 2020 | 1 | 252 |
| 2021 | 6 | 198 |
| 2022 | 5 | 230 |
| 2023 | 3 | 143 |
| 2025 | 3 | 143 |
| 2026 | 1 | 90 |
Compare with all 510(k) review times · Search every OLP clearance
Top OLP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nutra Luxe MD, LLC | 4 | 2016-12-15 |
| Led Technologies, Inc. | 3 | 2021-12-21 |
| Shenzhen Kaiyan Medical CO , Ltd. | 2 | 2021-07-22 |
| Led Intellectual Properties, LLC | 2 | 2015-01-29 |
| Silver Bay, LLC | 2 | 2012-01-18 |
38 more applicants have OLP clearances. See the full list in Caduvo.
Most recent OLP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253878 | Shenzhen Kaiyan Medical Equipment Co., Ltd. | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | 2026-03-04 | 90 |
| K251843 | Erchonia Corporation | Erchonia EVRL | 2025-09-12 | 88 |
| K242068 | Ningbo Dechang Electrical Machinery Made Co.,Ltd | LED Light Therapy Mask (RT01) | 2025-04-04 | 263 |
| K243555 | Shenzhen Eyco Technology Co., Ltd. | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | 2025-02-05 | 79 |
| K232656 | Premier North America, Inc. | BLU TOTALE (Model: ENEOB852) | 2023-11-14 | 75 |
Recalls for OLP devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-04.
| Year | Recalls |
|---|---|
| 2017 | 4 |
Frequently asked questions
What is FDA product code OLP?
OLP is the FDA product code for over-the-counter powered light based laser for acne. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel.
What device class is OLP?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLP?
Across 51 cleared submissions the average was 181 days from receipt to decision (median 159).
Which companies have the most OLP clearances?
Nutra Luxe MD, LLC (4); Led Technologies, Inc. (3); Shenzhen Kaiyan Medical CO , Ltd. (2); Led Intellectual Properties, LLC (2); Silver Bay, LLC (2).
Have OLP devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2017-12-04.
Next steps
- Run an FDA pathway report with predicate devices for product code OLP
- Run a recall and safety report across every OLP manufacturer
- Watch product code OLP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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