The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Smoothbeam Laser System.
| Device ID | K014128 |
| 510k Number | K014128 |
| Device Name: | CANDELA SMOOTHBEAM LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Lorraine Nelson |
| Correspondent | Lorraine Nelson 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 | 2001-12-17 |
| Decision Date | 2002-10-04 |
| Summary: | summary |