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Cryo 7

Zimmer Medizinsysteme GmbH

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

Zimmer Medizinsysteme GmbH
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K220020
Device name
Cryo 7
Company
Zimmer Medizinsysteme GmbH
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-01-05
Decision date
2022-02-04
Submission type
Special
Technology type
Other(AI inferred)
Clinical applications
Skin tightening
Primary application
Skin tightening
Classification source
AI classified

Indications for Use

The Cryo 7 is indicated to be used to:

Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Intended Use

The Cryo 7 is indicated to be used to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Device Description

The Cryo 7 Cold Air Device utilizes a compressor, evaporator and fan to cool the patient's skin locally and contactless. Cold air is produced which is then directed onto the skin. Conduction, evaporation, and forced convection cool the skin. The device operates on a mains voltage of 100V - 120V / 50-60Hz and has a maximum power consumption of 10A.

Summary parsed at:2026-06-01 05:39:23 UTC

Predicate devices

1

K220020 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K220020 as a predicate