510(k) K103118 ยท GEX Powered Laser Surgical Instrument
REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
| Applicant | Hoya Photonics, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Nov 19, 2010 |
| Received | Oct 21, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103118
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2013 | ConBio, a CynoSure Company Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser.
The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatme Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.