The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Andela Dynamic Cooling Device.
| Device ID | K951033 |
| 510k Number | K951033 |
| Device Name: | ANDELA DYNAMIC COOLING DEVICE |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Thomas R Varricchione |
| Correspondent | Thomas R Varricchione CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-06 |
| Decision Date | 1996-08-15 |
| Summary: | summary |