The following data is part of a premarket notification filed by Endo Optics, Inc. with the FDA for The Endo Optiks Microprobe.
| Device ID | K924090 |
| 510k Number | K924090 |
| Device Name: | THE ENDO OPTIKS MICROPROBE |
| Classification | Photocoagulator And Accessories |
| Applicant | ENDO OPTICS, INC. C/O KNOPF ASSOCIATES, INC. 28 MARIGOLD LANE Marlboro, NJ 07746 |
| Contact | Martin S Knopf |
| Correspondent | Martin S Knopf ENDO OPTICS, INC. C/O KNOPF ASSOCIATES, INC. 28 MARIGOLD LANE Marlboro, NJ 07746 |
| Product Code | HQB |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-13 |
| Decision Date | 1993-02-01 |