The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Pltl-1 Laser System: Pigmented Lesion Laser And Tatulazr.
| Device ID | K934706 |
| 510k Number | K934706 |
| Device Name: | CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Thomas R Varricchione, Mba, Rrt |
| Correspondent | Thomas R Varricchione, Mba, Rrt 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 | 1993-09-30 |
| Decision Date | 1994-04-29 |