The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Family Of Q-switched Alexandrite Lasers.
| Device ID | K081324 |
| 510k Number | K081324 |
| Device Name: | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA CORP. 530 BOSTON POST ROAD Wayland, MA 01778 |
| Contact | Lisa Lacroix |
| Correspondent | Lisa Lacroix 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 | 2008-05-12 |
| Decision Date | 2008-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817495020204 | K081324 | 000 |
| 00817495022178 | K081324 | 000 |
| 00817495022161 | K081324 | 000 |
| 00817495022154 | K081324 | 000 |
| 00817495022130 | K081324 | 000 |
| 00817495022123 | K081324 | 000 |
| 00817495022611 | K081324 | 000 |
| 00817495022604 | K081324 | 000 |
| 00817495022598 | K081324 | 000 |
| 00817495022581 | K081324 | 000 |
| 00817495022772 | K081324 | 000 |
| 00817495022765 | K081324 | 000 |
| 00817495021577 | K081324 | 000 |
| 00817495022017 | K081324 | 000 |
| 00817495020051 | K081324 | 000 |
| 00817495022185 | K081324 | 000 |
| 00817495022192 | K081324 | 000 |
| 00817495020297 | K081324 | 000 |
| 00817495020860 | K081324 | 000 |
| 00817495020853 | K081324 | 000 |
| 00817495020846 | K081324 | 000 |
| 00817495020563 | K081324 | 000 |
| 00817495020556 | K081324 | 000 |
| 00817495020549 | K081324 | 000 |
| 00817495020532 | K081324 | 000 |
| 00817495020525 | K081324 | 000 |
| 00817495020518 | K081324 | 000 |
| 00817495020495 | K081324 | 000 |
| 00817495020457 | K081324 | 000 |
| 00817495020440 | K081324 | 000 |
| 00817495020396 | K081324 | 000 |
| 00817495020389 | K081324 | 000 |
| 00817495021133 | K081324 | 000 |