The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Sptl-1e Pulsed Dye Laser.
| Device ID | K011092 |
| 510k Number | K011092 |
| Device Name: | CANDELA SPTL-1E PULSED DYE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Joan Clifford |
| Correspondent | Joan Clifford CANDELA 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 | 2001-04-10 |
| Decision Date | 2001-07-09 |