CO2RE system FG70412

GUDID 00817495024264

CO2RE System, Packaged

Candela Corporation

Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system

• Primary Device ID: 00817495024264
• NIH Device Record Key: 1be44af4-ca11-44c1-a3b8-968ac91caf10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO2RE system
• Version Model Number: FG70412
• Catalog Number: FG70412
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com
• Phone: 8007352737
• Email: customerservice@syneron-candela.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495024264 [Primary]
GS1	07290109950785 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181523

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: 2023-10-30
• Device Publish Date: 2023-10-20

Devices Manufactured by Candela Corporation

• 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
• 00817495023854 - GMPP Modified LSDS (HRDS) Options Kit for DCD: 2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for DCD
• 00817495023915 - GMPP Modified LSDS (HRDS) Options Kit for ACC: 2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for ACC
• 00817495025032 - HRDS Handpiece DCD Cooled: 2024-02-28 HRDS Handpiece DCD Cooled
• 00817495025049 - HRDS Handpiece Air Cooled: 2024-02-28 HRDS Handpiece Air Cooled
• 00817495024882 - Canister HFO-R1234 ZE / 950g, ALUM (US): 2024-02-12 Canister HFO-R1234 ZE / 950g, ALUM (US)
• 00817495024905 - Canister HFO-R1234 ZE / 950g, ALUM (Japan): 2024-02-12 Canister HFO-R1234 ZE / 950g, ALUM (Japan)