The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Model Spt-1, Pulsed Dye Laser.
| Device ID | K861179 |
| 510k Number | K861179 |
| Device Name: | CANDELA MODEL SPT-1, PULSED DYE LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA CORP. 19 STRATHMORE RD. Natick, MA 01760 |
| Contact | Ronald L Carroll |
| Correspondent | Ronald L Carroll CANDELA CORP. 19 STRATHMORE RD. Natick, MA 01760 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1986-11-20 |