510(k) K103338 ยท PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
COOLTOUCH
| Applicant | New Star Lasers, Inc., Roseville CA, US |
| Decision | Substantially Equivalent, Nov 1, 2011 |
| Received | Nov 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2016 | New Star Lasers, Inc. VariaBreeze; Catalog number: 7300-0035-2.
Podiatry:
ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, ra Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.