Cleared Traditional

K954872 - CANDELA CRYO-PROBE HOLDER

K954872 is an FDA 510(k) clearance for CANDELA CRYO-PROBE HOLDER, manufactured by Candela Laser Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K954872 · Candela Laser Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
104d
Days
Class 2
Risk

K954872 is an FDA 510(k) clearance for the CANDELA CRYO-PROBE HOLDER. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Candela Laser Corp. (Wayland, US). The FDA issued a Cleared decision on February 5, 1996 after a review of 104 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Candela Laser Corp. devices

FDA 510(k) Submission Details - K954872

510(k) Number K954872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1995
Decision Date February 05, 1996
Days to Decision 104 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 206
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K954872.
UROSPROBE SYSTEM, MODEL 1000
K960387 · Uros Corp. · Apr 1996
MEDI-FRIG
K954703 · Ellman Intl., Inc. · Feb 1996
VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION)
K955083 · Cryosurgery, Inc. · Feb 1996
CANDELA CRYOSYSTEM CS-5
K953294 · Candela Laser Corp. · Oct 1995
ERBOKRYO CA CRYOSURGICAL SYSTEM
K934261 · Erbe Elektromedizin GmbH · Apr 1994
WALLACH ULTRA FREEZE
K935010 · Wallach Surgical Devices, Inc. · Feb 1994