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FDA 510(k)

Freezpoint

K-Number: K180211 · 2018-03-21

ApplicantBovie Medical Corp.
Decision Date2018-03-21
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Freezpoint is a medical device manufactured by Bovie Medical Corp.. It received FDA 510(k) clearance on 2018-03-21 under approval number K180211. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freezpoint?

Freezpoint is a medical device that received FDA 510(k) clearance on 2018-03-21. It is manufactured by Bovie Medical Corp.. The 510(k) number is K180211.

When was Freezpoint approved by the FDA?

Freezpoint received FDA 510(k) clearance on 2018-03-21, under approval number K180211.

What company makes Freezpoint?

Freezpoint is manufactured by Bovie Medical Corp..

What is the FDA product code for Freezpoint?

The FDA product code for Freezpoint is GEH.

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K162695truFreeze SystemCSA Medical, Inc. K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd. K161480R2 Dermal Cooling SystemR2 Dermatology K161294Compound W Wart Removal System Dual PowerMedtech Products, Inc. K161615AccurettH&O Equipments, Nv/Sa K161557truFreeze SystemCSA Medical, Inc.

Official Source

View on FDA Database →

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

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