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 |
|---|---|---|---|
| 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 |
| 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 |
| K253279 | heat in a click | Feather/numiere 05 06 07 (05) | 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 |
| K253086 | sunglor technology co | LED Light Therapy Device (Models: SG-FM, SG-FE) | December 19, 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 |
| K252983 | shenzhen goodwind technology development co | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) | December 17, 2025 |
| K252994 | guangdong ace-tec co | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, | December 8, 2025 |
| K252142 | shenzhen siken 3d technology development co | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB | December 5, 2025 |
| K252642 | shenzhen dachi communication co | Microcurrent Facial Device (CEC101, EEI101) | November 19, 2025 |
| K253073 | sunglor technology co | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) | November 19, 2025 |
| K252308 | atop lighting co | LED Beauty Mask (RLBXX) | November 13, 2025 |
| K252053 | touchbeauty beauty and health ( shenzhen ) co | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | October 27, 2025 |
| K252264 | shenzhen zhenxing ruitong technology co | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask | October 17, 2025 |
| K252093 | merchsource | Light Therapy Mask (1019055) | October 16, 2025 |