SA Small Repl. Cover 10x13mm, 4Hr, Velashape III AS83322

GUDID 00817495024516

SA Small Repl. Cover 10x13mm, 4Hr, Velashape III

Candela Corporation

Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system

• Primary Device ID: 00817495024516
• NIH Device Record Key: ee33e7fb-884f-4cbc-897a-66e463b7ec5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SA Small Repl. Cover 10x13mm, 4Hr, Velashape III
• Version Model Number: AS83322
• Catalog Number: AS83322
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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	00817495024516 [Primary]
GS1	07290109950419 [Previous]

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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)