The following data is part of a premarket notification filed by Candela Corporation with the FDA for Picoway Laser System.
| Device ID | K191685 |
| 510k Number | K191685 |
| Device Name: | PicoWay Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Candela Corporation 530 Boston Post Road Wayland, MA 01778 |
| Contact | Brenda Geary |
| Correspondent | Brenda Geary Candela Corporation 530 Boston Post Road 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 | 2019-06-24 |
| Decision Date | 2019-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08174950202844 | K191685 | 000 |
| 00817495022871 | K191685 | 000 |
| 00817495022864 | K191685 | 000 |
| 00817495027210 | K191685 | 000 |
| 00817495022840 | K191685 | 000 |
| 00817495023595 | K191685 | 000 |
| 00817495022680 | K191685 | 000 |
| 00817495022673 | K191685 | 000 |
| 00817495022666 | K191685 | 000 |
| 00817495022574 | K191685 | 000 |
| 00817495022413 | K191685 | 000 |
| 00817495022406 | K191685 | 000 |
| 00817495021546 | K191685 | 000 |
| 00817495021386 | K191685 | 000 |
| 00817495022888 | K191685 | 000 |
| 00817495022895 | K191685 | 000 |
| 08174950202929 | K191685 | 000 |
| 08174950202905 | K191685 | 000 |
| 08174950202899 | K191685 | 000 |
| 08174950202882 | K191685 | 000 |
| 08174950202875 | K191685 | 000 |
| 08174950202868 | K191685 | 000 |
| 08174950202721 | K191685 | 000 |
| 08174950203100 | K191685 | 000 |
| 00817495021010 | K191685 | 000 |
| 08174950227212 | K191685 | 000 |
| 00817495023106 | K191685 | 000 |
| 00817495022925 | K191685 | 000 |
| 00817495022901 | K191685 | 000 |
| 00817495023113 | K191685 | 000 |