The following data is part of a premarket notification filed by Candela Corp. with the FDA for Vbeam Prima Laser System.
| Device ID | K183452 |
| 510k Number | K183452 |
| Device Name: | Vbeam Prima Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Candela Corp. 530 Boston Post Road Wayland, MA 01778 |
| Contact | Sharon Timberlake |
| Correspondent | Sharon Timberlake Candela Corp. 530 Boston Post Road Wayland, MA 01778 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-13 |
| Decision Date | 2019-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08174950202950 | K183452 | 000 |
| 00817495023274 | K183452 | 000 |
| 00817495023281 | K183452 | 000 |
| 00817495023298 | K183452 | 000 |
| 00817495023304 | K183452 | 000 |
| 00817495022932 | K183452 | 000 |
| 00817495022949 | K183452 | 000 |
| 00817495022956 | K183452 | 000 |
| 00817495022963 | K183452 | 000 |
| 00817495023007 | K183452 | 000 |
| 00817495023014 | K183452 | 000 |
| 08174950202820 | K183452 | 000 |
| 08174950202837 | K183452 | 000 |
| 08174950202936 | K183452 | 000 |
| 08174950202943 | K183452 | 000 |
| 00817495024585 | K183452 | 000 |