The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Elliptical Spot Handpiece.
| Device ID | K945587 |
| 510k Number | K945587 |
| Device Name: | CANDELA ELLIPTICAL SPOT HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Thomas R Varricchione |
| Correspondent | Thomas R 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 | 1994-11-14 |
| Decision Date | 1994-12-08 |