The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Sptl-1 Laser For Treating Benign Vasc. Les.
Device ID | K900858 |
510k Number | K900858 |
Device Name: | CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES |
Classification | Powered Laser Surgical Instrument |
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 | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-23 |
Decision Date | 1990-10-03 |