The following data is part of a premarket notification filed by Quantel Medical with the FDA for Supra Twin Ophthalmic Laser Photocoagulator.
| Device ID | K081946 |
| 510k Number | K081946 |
| Device Name: | SUPRA TWIN 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 | 2008-07-08 |
| Decision Date | 2009-03-25 |
| Summary: | summary |