The following data is part of a premarket notification filed by Ophthalmic Technologies, Inc. with the FDA for Di-rhex Ophthalmic Diathermy System.
| Device ID | K990064 |
| 510k Number | K990064 |
| Device Name: | DI-RHEX OPHTHALMIC DIATHERMY SYSTEM |
| Classification | Apparatus, Cautery, Radiofrequency, Ac-powered |
| Applicant | OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario, CA Mej 3e5 |
| Contact | George Myers |
| Correspondent | George Myers OPHTHALMIC TECHNOLOGIES, INC. 37 KODIAK CRESCENT, UNIT 12 Downsview, Ontario, CA Mej 3e5 |
| Product Code | HQR |
| CFR Regulation Number | 886.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-08 |
| Decision Date | 1999-04-04 |
| Summary: | summary |