Manufacturer
Air Liquide Healthcare America CorporationPURE CRYOGEN
Air Liquide Healthcare America Corporation
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K153564
- Device name
- PURE CRYOGEN
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-12-14
- Decision date
- 2016-03-29
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Hair removalVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
PURE CRYOGEN is indicated to be used as an accessory to Candela Corporation's Dynamic Cooling Device as a source of skin refrigerant fluid. The intended use of PURE CRYOGEN is (1) cooling of the skin prior to laser treatment, (2) reduction of pain during laser treatment, (3) allows for use of higher laser fluences for laser treatments, such as for hair removal and vascular lesions, and (4) reduces potential side effects of laser treatments, such as for hair removal and vascular lesions.
Intended Use
PURE CRYOGEN is indicated to be used as an accessory to Candela Corporation's Dynamic Cooling Device as a source of skin refrigerant fluid. The intended use of PURE CRYOGEN is (1) cooling of the skin prior to laser treatment, (2) reduction of pain during laser treatment, (3) allows for use of higher laser fluences for laser treatments, such as for hair removal and vascular lesions, and (4) reduces potential side effects of laser treatments, such as for hair removal and vascular lesions.
Device Description
Air Liquide's PURE CRYOGEN consists of a disposable, non-refillable cylinder containing 1,1,1,2-Tetrafluoroethane, commonly referred to as HFC-134a Low NAG gas ('134a gas'). The 134a gas cylinder is intended to be used as an accessory to Candela Corporation's Dynamic Cooling Device™ as a source of skin refrigerant fluid. The cylinder may be inserted into the Dynamic Cooling Device, which is then connected in line with Candela's laser device. Candela's laser controls the delivery of a pulsed spray of 134a gas just prior to the delivery of a laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. Use of the 134a gas prior to laser treatment minimizes thermal damage to skin during laser treatment and reduces pain associated with laser treatment.Summary parsed at:2026-06-01 06:05:31 UTC
Predicate devices
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K153564 references 1 predicate/reference device
Cited as predicate
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