The following data is part of a premarket notification filed by Hoya Conbio, Inc with the FDA for Revlite Q-switched Nd:yag Laser.
| Device ID | K063112 |
| 510k Number | K063112 |
| Device Name: | REVLITE Q-SWITCHED ND:YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HOYA CONBIO, INC 1105 SUNSET CREEK LANE Pleasanton, CA 94566 |
| Contact | Donna K Templeman |
| Correspondent | Donna K Templeman HOYA CONBIO, INC 1105 SUNSET CREEK LANE Pleasanton, CA 94566 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-11 |
| Decision Date | 2006-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494100544 | K063112 | 000 |
| 00841494100223 | K063112 | 000 |