FDA product code OHS: Light Based Over The Counter Wrinkle Reduction
OHS is the FDA product code for light based over the counter wrinkle reduction. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 163 510(k) submissions under OHS, 110 in the last five years, from 100 different applicants. The average 510(k) review took 129 days (median 90); 96 days on average over the last three years. FDA has posted 4 recalls for OHS devices.
Definition
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
Classification
| Field | Value |
|---|---|
| Device name | Light Based Over The Counter Wrinkle Reduction |
| 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 OHS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 140 |
| 2018 | 7 | 114 |
| 2019 | 4 | 86 |
| 2020 | 2 | 72 |
| 2021 | 7 | 215 |
| 2022 | 16 | 132 |
| 2023 | 12 | 124 |
| 2024 | 16 | 90 |
| 2025 | 42 | 105 |
| 2026 | 24 | 92 |
Compare with all 510(k) review times · Search every OHS clearance
Top OHS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | 15 | 2026-06-16 |
| Led Technologies, Inc. | 9 | 2022-12-21 |
| Light Tree Ventures Europe B.V. | 7 | 2026-05-12 |
| Led Intellectual Properties, LLC | 6 | 2026-07-31 |
| Guangdong Newdermo Biotech Co., Ltd. | 4 | 2026-06-29 |
95 more applicants have OHS clearances. See the full list in Caduvo.
Most recent OHS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260767 | Kam Yuen Plastic Products , Ltd. | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) | 2026-08-31 | 175 |
| K261602 | Shenzhen Goodwind Technology Development Co., Ltd. | Eye Recovery Pro (PH-e03) | 2026-08-10 | 88 |
| K261601 | Shenzhen Chuangtong Yigou Technology Co., Ltd. | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | 2026-08-07 | 85 |
| K261496 | Duplex International Trading Limited | LED Light Therapy Masks (PE748, PE749, PE756) | 2026-08-04 | 90 |
| K261851 | Shenzhen Qianyu Technology Co., Ltd. | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) | 2026-08-04 | 62 |
Recalls for OHS devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-06-29.
| Year | Recalls |
|---|---|
| 2018 | 3 |
Frequently asked questions
What is FDA product code OHS?
OHS is the FDA product code for light based over the counter wrinkle reduction. 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 OHS?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code OHS?
Across 163 cleared submissions the average was 129 days from receipt to decision (median 90).
Which companies have the most OHS clearances?
Shenzhen Kaiyan Medical Equipment Co., Ltd. (15); Led Technologies, Inc. (9); Light Tree Ventures Europe B.V. (7); Led Intellectual Properties, LLC (6); Guangdong Newdermo Biotech Co., Ltd. (4).
Have OHS devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2018-06-29.
Next steps
- Run an FDA pathway report with predicate devices for product code OHS
- Run a recall and safety report across every OHS manufacturer
- Watch product code OHS 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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