Capillus CP202XL

GUDID 00853327006299

Cap for hair regrowth, extra-large, photobiomodulation

CAPILLUS, LLC

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• Primary Device ID: 00853327006299
• NIH Device Record Key: f097038a-ed29-4e68-bf96-a1bfd2070f57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capillus
• Version Model Number: 202XL
• Catalog Number: CP202XL
• Company DUNS: 079813345
• Company Name: CAPILLUS, LLC
• 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	00853327006299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153618

FDA Product Code

• OAP: Laser, Comb, Hair

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [Capillus]

• 00853327006299: Cap for hair regrowth, extra-large, photobiomodulation
• 00853327006220: Cap for hair regrowth, stand mount, photobiomodulation
• 00853327006213: Cap for hair regrowth, photobiomodulation
• 00853327006206: Cap for hair regrowth, photobiomodulation
• 00853327006190: Cap for hair regrowth, extra-large, photobiomodulation
• 00853327006183: Cap for hair regrowth, photobiomodulation
• 00810045461021: Hair growth laser device
• 00853327006763: Cap for hair growth, photobiomodulation.