The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Retinal Camera.
| Device ID | K913314 |
| 510k Number | K913314 |
| Device Name: | CANDELA RETINAL CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | George Cho |
| Correspondent | George Cho CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-25 |
| Decision Date | 1992-01-23 |