GentleCool Pro Packaged 15-Pack of Cryogen (R134a / 980g / US) FIN103321

GUDID 00817495024004

Packaged 15-Pack of Cryogen (R134a / 980g / US)

Candela Corporation

Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system

• Primary Device ID: 00817495024004
• NIH Device Record Key: 553c737e-ff77-40cd-8b9f-44e9c9a084ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GentleCool Pro Packaged 15-Pack of Cryogen (R134a / 980g / US)
• Version Model Number: FIN103321
• Catalog Number: FIN103321
• Company DUNS: 053468385
• Company Name: Candela Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495024004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001589

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-31
• Device Publish Date: 2024-05-23

Devices Manufactured by Candela Corporation

• 00817495024011 - MSDS DCD Option Kit GMPP: 2024-07-04 MSDS DCD Option Kit GMPP
• 00817495023946 - Modified LSDS Fiber Assembly, 12-26 mm: 2024-06-25 Modified LSDS Fiber Assembly 12-26 mm
• 00817495023984 - GentleCool Pro Canister Cryogen (R134a / 980g / US): 2024-05-31 Canister Cryogen (R134a / 980g / US)
• 00817495024004 - GentleCool Pro Packaged 15-Pack of Cryogen (R134a / 980g / US): 2024-05-31Packaged 15-Pack of Cryogen (R134a / 980g / US)
• 00817495024004 - GentleCool Pro Packaged 15-Pack of Cryogen (R134a / 980g / US): 2024-05-31 Packaged 15-Pack of Cryogen (R134a / 980g / US)
• 00817495020587 - Packaged 15-Pack of Cryogen (R134a / 980g / US): 2024-05-06 Packaged 15-Pack of Cryogen (R134a / 980g / US)
• 00817495023649 - Packaged 15-Pack of Cryogen (R134a / 980g / JP): 2024-05-06 Packaged 15-Pack of Cryogen (R134a / 980g / JP)
• 00817495024370 - Profound, SubQ Single- Use Cartridge, Packaged: 2024-03-08 Profound, SubQ Single- Use Cartridge, Packaged
• 00817495024387 - Profound, Dermal Single- Use Cartridge, Packaged: 2024-03-08 Profound, Dermal Single- Use Cartridge, Packaged