The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela H:erb Laser.
| Device ID | K921995 |
| 510k Number | K921995 |
| Device Name: | CANDELA H:ERB LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Thomas Varricchione |
| Correspondent | Thomas Varricchione CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-28 |
| Decision Date | 1994-11-07 |