PURE CRYOGEN

Air Liquide Healthcare America Corporation

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

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

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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

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