Applicator VLS 555 555 - 950 nm

GUDID 00817495023397

CANDELA CORPORATION

Multi-modality skin surface treatment system

• Primary Device ID: 00817495023397
• NIH Device Record Key: 2e652b88-1e05-4b0e-ad04-b429b12e76f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Applicator VLS 555 555 - 950 nm
• Version Model Number: 9APP7814-CNDL
• 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	00817495023397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150907

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: 2021-01-25
• Device Publish Date: 2021-01-15

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)