The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Dynamic Cooling Device.
| Device ID | K001589 |
| 510k Number | K001589 |
| Device Name: | CANDELA DYNAMIC COOLING DEVICE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CANDELA CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Joan M Clifford |
| Correspondent | Joan M Clifford CANDELA CORP. 530 BOSTON POST RD. 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 | 2000-05-23 |
| Decision Date | 2000-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817495023601 | K001589 | 000 |
| 00817495024905 | K001589 | 000 |
| 00817495024943 | K001589 | 000 |
| 00817495024967 | K001589 | 000 |
| 00817495025001 | K001589 | 000 |
| 00817495025025 | K001589 | 000 |
| 00817495023632 | K001589 | 000 |
| 00817495023618 | K001589 | 000 |
| 00817495023625 | K001589 | 000 |
| 00817495023670 | K001589 | 000 |
| 00817495024882 | K001589 | 000 |