Regular Internal Handpiece Sterile Single-Use, CO2RE Intima

GUDID 00817495025056

Regular Internal Handpiece Sterile Single-Use, Blister Packaged, CO2RE Intima

Candela Corporation

Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece

• Primary Device ID: 00817495025056
• NIH Device Record Key: 5f3b84ff-343a-45df-b643-dd914c7adaa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regular Internal Handpiece Sterile Single-Use, CO2RE Intima
• Version Model Number: AS95191
• 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: true
• Lot Batch: false
• 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	00817495025056 [Primary]

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: true

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

• 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): 2024-05-31 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