Cleared Special

K080735 - CRYOMINI

K080735 is an FDA 510(k) clearance for CRYOMINI, manufactured by Zimmer Elektromedizin GmbH. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Special 510(k) pathway after a 18-day FDA review.

K080735 · Zimmer Elektromedizin GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
18d
Days
Class 2
Risk

K080735 is an FDA 510(k) clearance for the CRYOMINI. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Zimmer Elektromedizin GmbH (Neu-Elm, DE). The FDA issued a Cleared decision on April 4, 2008 after a review of 18 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zimmer Elektromedizin GmbH devices

FDA 510(k) Submission Details - K080735

510(k) Number K080735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2008
Decision Date April 04, 2008
Days to Decision 18 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 Consultant

Tuv Sud America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 2322
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K080735.
COOLTOUCH MODELS LC215 AND COOLLIPO
K080163 · New Star Lasers, Inc. · Apr 2008
PHARAON LIPO
K073617 · Osyris · Apr 2008
SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
K080697 · Global USA Distribution, LLC · Apr 2008
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
K073534 · Candela Corp. · Apr 2008
MODIFICATION TO PALOMAR LUX1540 HANDPIECE
K073583 · Palomar Medical Products, Inc. · Mar 2008
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542
K080104 · Vascular Solutions, Inc. · Mar 2008

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.