The following data is part of a premarket notification filed by Hoya Conbio, Inc with the FDA for Revlite Q-switched Nd:yag Laser System.
| Device ID | K083899 |
| 510k Number | K083899 |
| Device Name: | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HOYA CONBIO, INC 19722 WESTVIEW DRIVE Twain Harte, CA 95383 |
| Contact | Liza Burns |
| Correspondent | Liza Burns HOYA CONBIO, INC 19722 WESTVIEW DRIVE Twain Harte, CA 95383 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-06-01 |
| Summary: | summary |