The following data is part of a premarket notification filed by Vision-sciences, Inc. with the FDA for Formalens 2000.
| Device ID | K863367 |
| 510k Number | K863367 |
| Device Name: | FORMALENS 2000 |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | VISION-SCIENCES, INC. 140 EAST DUARTE RD. Monrovia, CA 91016 |
| Contact | Howard Silverman |
| Correspondent | Howard Silverman VISION-SCIENCES, INC. 140 EAST DUARTE RD. Monrovia, CA 91016 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-03 |
| Decision Date | 1986-09-26 |