Manufacturer
Zimmer Medizinsysteme GmbHCryo 7
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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—
—
Not ingested
K220020 references 1 predicate/reference device
Cited as predicate
1Cryojet Plus (SHE-ACP001-1)
1 submission cite K220020 as a predicate