Frax 1940

GUDID 00817495023489

Frax 1940 ( Laser)

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 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: 00817495023489
• NIH Device Record Key: 688349dc-a45b-47f6-bd6f-196eb15ca79c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Frax 1940
• Version Model Number: 9APP7908
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495023489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192951

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: 2022-02-17
• Device Publish Date: 2022-02-09

Devices Manufactured by CANDELA CORPORATION

• 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
• 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