The following data is part of a premarket notification filed by Candela Corporation with the FDA for Picoway Laser System.
| Device ID | K150326 |
| 510k Number | K150326 |
| Device Name: | PicoWay Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Candela Corporation 530 Boston Post Road Wayland, MA 01778 |
| Contact | Ruthie Amir |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, MA 19103 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-04-16 |
| Summary: | summary |