ASSY, ACC HAND PIECE, LARGE SPOT, GMPP

GUDID 00817495022987

Delivery System Assembly

CANDELA CORPORATION

Dermatological solid-state laser system

• Primary Device ID: 00817495022987
• NIH Device Record Key: 28a2860f-69cf-4e68-b0d7-f62f7c61a331
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSY, ACC HAND PIECE, LARGE SPOT, GMPP
• Version Model Number: 7123-00-0628
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495022987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201111

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: 2022-01-25
• Device Publish Date: 2022-01-17

On-Brand Devices [ASSY, ACC HAND PIECE, LARGE SPOT, GMPP]

• 00817495022987: Delivery System Assembly
• 00817495023977: ASSY, ACC HAND PIECE, LARGE SPOT, GMPP