The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Model Pltl-1 Laser System.
| Device ID | K953412 |
| 510k Number | K953412 |
| Device Name: | CANDELA MODEL PLTL-1 LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA LASER CORP. 555 THIRTEENTH STREET, N.W Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan CANDELA LASER CORP. 555 THIRTEENTH STREET, N.W Washington, DC 20004 -1109 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-20 |
| Decision Date | 1995-10-24 |