The following data is part of a premarket notification filed by Marco Ophthalmic, Inc. with the FDA for Elios Diode Ophthalmic Laser.
| Device ID | K921320 |
| 510k Number | K921320 |
| Device Name: | ELIOS DIODE OPHTHALMIC LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville, FL 32224 |
| Contact | Scott E Lewis |
| Correspondent | Scott E Lewis MARCO OPHTHALMIC, INC. 11825 CENTRAL PKWY. Jacksonville, FL 32224 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-19 |
| Decision Date | 1992-07-02 |