OHS — Light Based Over The Counter Wrinkle Reduction Class II
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 |
|---|---|---|---|
| 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 |
| K254007 | sz kks silicone and electronic co | LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) | February 12, 2026 |
| K253833 | shenzhen jianchao intelligent technology co | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD0 | January 30, 2026 |
| K252603 | shenzhen kaiyan medical equipment co | HIGHERDOSE Body Sculptor (Model: GS-03) | January 28, 2026 |
| K253712 | shenzhen rainbow technology co | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, | January 23, 2026 |
| K253279 | heat in a click | Feather/numiere 05 06 07 (05) | December 24, 2025 |
| K253400 | shenzhen saidi light therapy technology co | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X | December 24, 2025 |
| K253135 | dongguan yijiaming technology co | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1 | December 23, 2025 |
| K253054 | shenzhen xinlong precision plastic mold products co | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) | December 19, 2025 |
| K253086 | sunglor technology co | LED Light Therapy Device (Models: SG-FM, SG-FE) | December 19, 2025 |
| K252983 | shenzhen goodwind technology development co | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) | December 17, 2025 |