The following data is part of a premarket notification filed by Iridex Corporation with the FDA for Varilite Laser System.
| Device ID | K041930 |
| 510k Number | K041930 |
| Device Name: | VARILITE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | IRIDEX CORPORATION 1212 TERRA BELLA AVENUE Mountain View, CA 94043 -1824 |
| Contact | John Jossy |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-07-19 |
| Decision Date | 2004-09-10 |
| Summary: | summary |