The following data is part of a premarket notification filed by Quantel Medical with the FDA for Supra Ophthalmic Laser Photocoagulator.
| Device ID | K070776 |
| 510k Number | K070776 |
| Device Name: | SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR |
| Classification | Laser, Ophthalmic |
| Applicant | QUANTEL MEDICAL 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers QUANTEL MEDICAL 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-21 |
| Decision Date | 2007-04-24 |
| Summary: | summary |