The following data is part of a premarket notification filed by Candela Corporation with the FDA for Picoway Laser System.
| Device ID | K220853 |
| 510k Number | K220853 |
| Device Name: | PicoWay Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Candela Corporation 251 Locke Drive Marlborough, MA 01752 |
| Contact | Danielle Gibboney |
| Correspondent | Danielle Gibboney Candela Corporation 251 Locke Drive Marlborough, MA 01752 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-23 |
| Decision Date | 2022-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817495024141 | K220853 | 000 |
| 00817495022680 | K220853 | 000 |
| 00817495022673 | K220853 | 000 |
| 00817495022666 | K220853 | 000 |
| 00817495022574 | K220853 | 000 |
| 00817495022413 | K220853 | 000 |
| 00817495022406 | K220853 | 000 |
| 00817495021546 | K220853 | 000 |
| 00817495021386 | K220853 | 000 |
| 00817495021010 | K220853 | 000 |
| 00817495020037 | K220853 | 000 |
| 00817495021393 | K220853 | 000 |
| 00817495023588 | K220853 | 000 |
| 00817495023663 | K220853 | 000 |
| 00817495023540 | K220853 | 000 |
| 00817495022734 | K220853 | 000 |
| 00817495022741 | K220853 | 000 |
| 00817495022758 | K220853 | 000 |
| 00817495024134 | K220853 | 000 |
| 00817495023687 | K220853 | 000 |
| 00817495027210 | K220853 | 000 |
| 00817495023595 | K220853 | 000 |
| 00817495023113 | K220853 | 000 |
| 00817495023106 | K220853 | 000 |
| 00817495022925 | K220853 | 000 |
| 00817495022901 | K220853 | 000 |
| 00817495022895 | K220853 | 000 |
| 00817495022888 | K220853 | 000 |
| 00817495022871 | K220853 | 000 |
| 00817495022864 | K220853 | 000 |
| 00817495022840 | K220853 | 000 |
| 00817495022819 | K220853 | 000 |
| 00817495024677 | K220853 | 000 |