OHS — Light Based Over The Counter Wrinkle Reduction Class II
FDA product code OHS covers "Light Based Over The Counter Wrinkle Reduction", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OHS
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260767 | kam yuen plastic products | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beau | August 31, 2026 |
| K261602 | shenzhen goodwind technology development co | Eye Recovery Pro (PH-e03) | August 10, 2026 |
| K261601 | shenzhen chuangtong yigou technology co | LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | August 7, 2026 |
| K261851 | shenzhen qianyu technology co | LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML | August 4, 2026 |
| K261496 | duplex international trading limited | LED Light Therapy Masks (PE748, PE749, PE756) | August 4, 2026 |
| K261482 | led intellectual properties | LightStim for Wrinkles (1984); LightStim for Acne (2038) | July 31, 2026 |
| K260598 | ismart developments | 5 Wavelength LED Facemask (TN2508) | July 24, 2026 |
| K261407 | dongguan miqiang technology co | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPR | July 15, 2026 |
| K261473 | termosalud s.l | Chromix | July 1, 2026 |
| K261052 | guangdong newdermo biotech co | LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | June 29, 2026 |
| K260946 | guangdong newdermo biotech co | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | June 18, 2026 |
| K254025 | shenzhen kaiyan medical equipment co | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | June 16, 2026 |
| K260715 | beauty tech group | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | June 3, 2026 |
| K260415 | light tree ventures europe | myLEDmask 2 (MJ-144) | May 12, 2026 |
| K260150 | nooance | LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) | April 22, 2026 |
| K260202 | guangdong newdermo biotech co | LED Light Therapy Masks (LumiLips FAC07NA) | March 23, 2026 |
| K260511 | shenzhen ulike smart electronics co | Ulike Reglow Light Therapy Device (UM10) | March 16, 2026 |
| K254079 | shenzhen desida technology co | LED Light Therapy Mask (Models: T2, RLD10) | March 16, 2026 |
| K253874 | shenzhen hanhua opto co | LED Therapy Light (COB1400, HP1800PRO) | March 3, 2026 |
| K253683 | foreo | FAQ (LED Panel); FAQ (Dual LED Panel) | February 20, 2026 |