The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for Xe-lite.
| Device ID | K954263 |
| 510k Number | K954263 |
| Device Name: | XE-LITE |
| Classification | Lamp, Surgical |
| Applicant | OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario, CA Mej 3e5 |
| Contact | Rishard Weitz |
| Correspondent | Rishard Weitz OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario, CA Mej 3e5 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-12 |
| Decision Date | 1995-10-18 |