510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954872Substantially Equivalent

Candela Cryo-Probe Holder

Candela Corporation, Wayland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954872 is the FDA 510(k) clearance record for CANDELA CRYO-PROBE HOLDER, a class II device, cleared for Candela Laser Corp. on under FDA product code GEH (Unit, Cryosurgical, Accessories). FDA records list 99 510(k) clearances for Candela Corporation, from to . As of , FDA records show no recalls naming K954872.

Clearance record

Decision date
Received
(104 days to decision)
Product code
GEH Unit, Cryosurgical, Accessories
Regulation
21 CFR 878.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Candela Laser Corp. 530 Boston Post Rd., Wayland MA
510(k) summary
Summary
Third party review
No

Clearances, product code GEH

Trailing 12 months
9 clearances under product code GEH in the twelve months to November 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GEH, trailing twelve months
MonthClearances
December 20251
January 20261
February 20262
March 20260
April 20262
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260
November 20260