The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Family Of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, Sptl-1b.
| Device ID | K043251 |
| 510k Number | K043251 |
| Device Name: | CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Lorraine Calzetta |
| Correspondent | Lorraine Calzetta 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 | 2004-11-23 |
| Decision Date | 2005-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817495023496 | K043251 | 000 |
| 00817495020006 | K043251 | 000 |
| 00817495021447 | K043251 | 000 |
| 00817495021423 | K043251 | 000 |
| 00817495021362 | K043251 | 000 |