GentleYAG SR Delivery System W/DCD

GUDID 00817495021713

Delivery System Assembly

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 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: 00817495021713
• NIH Device Record Key: 34cc8e53-0b79-4a5c-a885-df9b0d0bd166
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GentleYAG SR Delivery System W/DCD
• Version Model Number: 0800-00-1058
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495021713 [Primary]
GS1	08174950201717 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140122

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-05-24
• Device Publish Date: 2016-09-23

On-Brand Devices [GentleYAG SR Delivery System W/DCD]

• 00817495021713: Delivery System Assembly
• 00817495021706: Delivery System Assembly
• 00817495021690: Delivery System Assembly
• 00817495021683: Delivery System Assembly
• 00817495021676: Delivery System Assembly
• 00817495021669: Delivery System Assembly