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Cryoflow 700, Cryoflow 1000

by Uniphy Elektromedizin GmbH & Co. KG

510(k) K052310

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK052310 Date15 Mar 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cryoflow 700 and Cryoflow 1000 are laser surgical instruments designed for use in general and plastic surgery and in dermatology. These devices are manufactured by Uniphy Elektromedizin GmbH & Co. KG and are classified under product code GEX.

The Cryoflow devices are supplied by Uniphy Elektromedizin GmbH & Co. KG located in Bilzen, Belgium. They have received FDA 510(k) clearance with number K052310 and are regulated under 21 CFR 878.4810. The devices are intended for use in general and plastic surgery settings.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the Cryoflow 700 and 1000 devices used for?

    The Cryoflow 700 and 1000 are laser surgical instruments specifically designed for use in general surgery, plastic surgery, and dermatology procedures. They are manufactured by Uniphy Elektromedizin GmbH & Co. KG and intended for surgical settings.

  • How are the Cryoflow devices supplied?

    The Cryoflow 700 and 1000 devices are supplied by Uniphy Elektromedizin GmbH & Co. KG, which is located at 6a Pasweg, Bilzen, Belgium. The company provides these laser surgical instruments to medical facilities for use in surgical procedures.

  • What is the regulatory status of the Cryoflow devices?

    The Cryoflow 700 and 1000 have received FDA 510(k) clearance with number K052310 and are regulated under 21 CFR 878.4810. They are classified under product code GEX and were determined to be substantially equivalent to predicate devices.

  • Are there different models of the Cryoflow device available?

    Yes, there are two models of the Cryoflow device available: the Cryoflow 700 and the Cryoflow 1000. Both are laser surgical instruments designed for similar applications in general and plastic surgery settings, though they may have different specifications or capabilities.