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FDA 510(k)

VENUS FREEZE SYSTEM

K-Number: K100586 · 2010-11-29

ApplicantVenus Concept , Ltd.
Decision Date2010-11-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VENUS FREEZE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept , Ltd.. It received FDA 510(k) clearance on 2010-11-29 under 510(k) number K100586. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENUS FREEZE SYSTEM?

VENUS FREEZE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-29. The listed applicant is Venus Concept , Ltd.. The 510(k) number is K100586.

When did VENUS FREEZE SYSTEM receive FDA 510(k) clearance?

VENUS FREEZE SYSTEM received FDA 510(k) clearance on 2010-11-29, under 510(k) number K100586.

Who is the listed applicant for VENUS FREEZE SYSTEM?

The FDA 510(k) record lists Venus Concept , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENUS FREEZE SYSTEM?

The FDA product code for VENUS FREEZE SYSTEM is GEI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Venus Concept , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162765Venus Velocity Diode Laser SystemK153717Venus Versa SystemK152790Venus Versa SystemK111670VENUS FREEZE (MP)2 SYSTEMK111784VENUS SWAN SYSTEM

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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