The following data is part of a premarket notification filed by Labtician Ophthalmics, Inc. with the FDA for Labtician Lid Load Gold Eyelid Weight Implants.
| Device ID | K983607 |
| 510k Number | K983607 |
| Device Name: | LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS |
| Classification | Weights, Eyelid, External |
| Applicant | LABTICIAN OPHTHALMICS, INC. 2140 WINSTON PARK DR., UNIT 6 Oakville, Ontario, CA L6h 5v5 |
| Contact | R. David Sculati |
| Correspondent | R. David Sculati LABTICIAN OPHTHALMICS, INC. 2140 WINSTON PARK DR., UNIT 6 Oakville, Ontario, CA L6h 5v5 |
| Product Code | MML |
| CFR Regulation Number | 886.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-14 |
| Decision Date | 1999-01-08 |
| Summary: | summary |