510(k) K180036 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
SMAXEL CO2 Surgical Laser System
| Applicant | Ids, Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Feb 2, 2018 |
| Received | Jan 5, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2025 | IDS LTD Smaxel Fractional CO2 Laser, a Class IV medical laser system. Open, Classified |
ONG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.