The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Mainster Retina Laser Lens.
| Device ID | K863911 |
| 510k Number | K863911 |
| Device Name: | MAINSTER RETINA LASER LENS |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue, WA 98005 |
| Contact | Tamsin J Erickson |
| Correspondent | Tamsin J Erickson OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue, WA 98005 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-08 |
| Decision Date | 1986-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630238123495 | K863911 | 000 |
| 00630238031608 | K863911 | 000 |
| 00630238058032 | K863911 | 000 |
| 00630238062374 | K863911 | 000 |
| 00630238066198 | K863911 | 000 |
| 00630238071956 | K863911 | 000 |
| 00630238075770 | K863911 | 000 |
| 00630238080989 | K863911 | 000 |
| 00630238091404 | K863911 | 000 |
| 00630238091473 | K863911 | 000 |
| 00630238091558 | K863911 | 000 |
| 00630238091626 | K863911 | 000 |
| 00630238097727 | K863911 | 000 |
| 00630238108751 | K863911 | 000 |
| 00630238110679 | K863911 | 000 |
| 00630238115568 | K863911 | 000 |
| 00630238123297 | K863911 | 000 |
| 00630238007603 | K863911 | 000 |