Home / 510(k) Clearances / K953294

510(k) K953294

CANDELA CRYOSYSTEM CS-5 by Candela Laser Corp. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1995
Date Received
July 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by Candela Laser Corp.

  • K951033 — ANDELA DYNAMIC COOLING DEVICE (August 15, 1996)
  • K955662 — CANDELA Q-SWITCHED ALEXANDRITE LASERS (June 14, 1996)
  • K955011 — CANDELA HCS 2000 URETHERAL WARMER CATHETER (April 3, 1996)
  • K954872 — CANDELA CRYO-PROBE HOLDER (February 5, 1996)
  • K954934 — CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE (February 2, 1996)
  • K953412 — CANDELA MODEL PLTL-1 LASER SYSTEM (October 24, 1995)
  • K950831 — ALEXLAZR (May 26, 1995)
  • K946386 — CANDELA RUBY LAZE Q-SWITCHED RUBY LASER (March 24, 1995)
  • K950661 — CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE (March 10, 1995)
  • K943292 — CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS (March 9, 1995)

Other clearances for product code GEH

  • K260377 — XSense Cryoablation System with CryoProbes (February 24, 2026)
  • K251928 — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control (February 13, 2026)
  • K251524 — Dr. Yglo Skin Tag Remover (January 12, 2026)
  • K250742 — Focused Cryotherapy System (December 9, 2025)
  • K253000 — CryoFreeze Wart and Skin Tag Remover (October 16, 2025)
  • K253114 — TargetCool™ (RM-DT02W) (October 16, 2025)
  • K253348 — TargetCool-e (October 15, 2025)
  • K252903 — Verruca-Freeze H Plus (October 10, 2025)
  • K251493 — Skin Clinic Freeze Point for Warts and Skin Tags (May 22, 2025)
  • K242932 — Skin Clinic Nitro Clear Wart Remover (April 15, 2025)