510(k) K253878 ยท OLP Over-The-Counter Powered Light Based Laser For Acne
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
| Applicant | Shenzhen Kaiyan Medical Equipment Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 4, 2026 |
| Received | Dec 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253878
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.