The following data is part of a premarket notification filed by Hoya Photonics, Inc. with the FDA for Revlite Q-switched Nd: Yag Laser System With Nadpiece Adaptor.
| Device ID | K103118 |
| 510k Number | K103118 |
| Device Name: | REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HOYA PHOTONICS, INC. 1105 SUNSET CREEK LANE Pleasanton, CA 94566 |
| Contact | Donna Templeman |
| Correspondent | Donna Templeman HOYA PHOTONICS, 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 | 2010-10-21 |
| Decision Date | 2010-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494107970 | K103118 | 000 |
| 00841494103651 | K103118 | 000 |
| 00841494100346 | K103118 | 000 |
| 00841494100339 | K103118 | 000 |
| 00841494100216 | K103118 | 000 |