Motif IR Applicator, elos Plus FG70911

GUDID 00817495024349

Motif IR Applicator, elos Plus

Candela Corporation

Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system

• Primary Device ID: 00817495024349
• NIH Device Record Key: ecbf2e91-d000-4972-9c8e-206974649f81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Motif IR Applicator, elos Plus
• Version Model Number: FG70911
• Catalog Number: FG70911
• 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	00817495024349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113868

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

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• 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