The following data is part of a premarket notification filed by Iridex Corp. with the FDA for Oculight Gl With The Dermatology Handpiece.
| Device ID | K982031 |
| 510k Number | K982031 |
| Device Name: | OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Contact | Daniel Marinsik |
| Correspondent | Daniel Marinsik IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-10 |
| Decision Date | 1998-09-08 |
| Summary: | summary |