The following data is part of a premarket notification filed by Synemed, Inc. with the FDA for Dermatology Handpiece-ophth Laser.
| Device ID | K833274 |
| 510k Number | K833274 |
| Device Name: | DERMATOLOGY HANDPIECE-OPHTH LASER |
| Classification | Laser, Ophthalmic |
| Applicant | SYNEMED, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-21 |
| Decision Date | 1983-12-03 |