GentleMax Delivery System

GUDID 00817495022109

Delivery System Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator

• Primary Device ID: 00817495022109
• NIH Device Record Key: 64c9af85-a791-47fa-96ff-17355945a916
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GentleMax Delivery System
• Version Model Number: 0800-00-1080
• 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	00817495022109 [Primary]
GS1	08174950202103 [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: 4
• Public Version Date: 2020-06-17
• Device Publish Date: 2016-09-23

Devices Manufactured by CANDELA CORPORATION

• 00817495023977 - ASSY, ACC HAND PIECE, LARGE SPOT, GMPP: 2024-09-05 ASSY, ACC HAND PIECE, LARGE SPOT, GMPP
• 00817495024028 - ASSY, DCD HAND PIECE, LARGE SPOT, GMPP: 2024-09-05 ASSY, DCD HAND PIECE, LARGE SPOT, GMPP
• 00817495024035 - GMPP DCD Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly: 2024-09-05 GMPP DCD Large Spot
• 00817495024042 - GMPP ACC Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly: 2024-09-05 GMPP ACC Large Spot
• 00817495024011 - MSDS DCD Option Kit GMPP: 2024-07-04 MSDS DCD Option Kit GMPP
• 00817495023946 - Modified LSDS Fiber Assembly, 12-26 mm: 2024-06-25 Modified LSDS Fiber Assembly 12-26 mm
• 00817495023984 - GentleCool Pro Canister Cryogen (R134a / 980g / US): 2024-05-31 Canister Cryogen (R134a / 980g / US)
• 00817495024004 - GentleCool Pro Packaged 15-Pack of Cryogen (R134a / 980g / US): 2024-05-31 Packaged 15-Pack of Cryogen (R134a / 980g / US)