The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Trokel /3 Gonio Laser Lens.
| Device ID | K921414 |
| 510k Number | K921414 |
| Device Name: | TROKEL /3 GONIO LASER LENS |
| Classification | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
| Applicant | OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
| Contact | Tamsin J Erickson |
| Correspondent | Tamsin J Erickson OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
| Product Code | LQJ |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-24 |
| Decision Date | 1992-11-16 |