primelase excellence 521028

GUDID 08437020651011

PRIMELASE diode laser hair removal system with 755nm, 810nm and 810 – 1060nm applicators include: • Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. • Treatment of Pseudofolliculitis barbae (PFB)

HIGH TECHNOLOGY PRODUCTS SL

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• Primary Device ID: 08437020651011
• NIH Device Record Key: 5cf28e19-e6d0-429b-b1ad-fe92b8c6befb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: primelase excellence
• Version Model Number: PRIMELASE diode laser hair removal system
• Catalog Number: 521028
• Company DUNS: 462514006
• Company Name: HIGH TECHNOLOGY PRODUCTS SL
• 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

Customer Support Contacts

• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com
• Phone: +34934588566
• Email: info@cocoonmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437020651011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191321

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: 2020-04-17
• Device Publish Date: 2020-04-09

Devices Manufactured by HIGH TECHNOLOGY PRODUCTS SL

• 08437020651141 - elysion-pro: 2020-11-09 ELYSION diode laser hair removal system with 755nm and 810nm and applicators include: • Hair Removal with Static and Dynamic m
• 08437020651011 - primelase excellence: 2020-04-17PRIMELASE diode laser hair removal system with 755nm, 810nm and 810 – 1060nm applicators include: • Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. • Treatment of Pseudofolliculitis barbae (PFB)
• 08437020651011 - primelase excellence: 2020-04-17 PRIMELASE diode laser hair removal system with 755nm, 810nm and 810 – 1060nm applicators include: • Hair Removal with Static