The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Family Of Pulse Dye Laser Systems.
| Device ID | K050673 |
| 510k Number | K050673 |
| Device Name: | CANDELA FAMILY OF PULSE DYE LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA CORP. 530 BOSTON POST RD. Wayland, MA 01886 |
| Contact | Lorraine Calzetta Patrovic |
| Correspondent | Lorraine Calzetta Patrovic CANDELA CORP. 530 BOSTON POST RD. Wayland, MA 01886 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-15 |
| Decision Date | 2005-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08174950202226 | K050673 | 000 |
| 08174950202219 | K050673 | 000 |
| 08174950202202 | K050673 | 000 |
| 08174950201373 | K050673 | 000 |
| 08174950200314 | K050673 | 000 |
| 08174950200307 | K050673 | 000 |
| 00817495021492 | K050673 | 000 |
| 00817495021485 | K050673 | 000 |
| 00817495021355 | K050673 | 000 |