The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Cryo-probe Holder.
| Device ID | K954872 |
| 510k Number | K954872 |
| Device Name: | CANDELA CRYO-PROBE HOLDER |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | Burton Salkin |
| Correspondent | Burton Salkin CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-24 |
| Decision Date | 1996-02-05 |