Sebacia Microparticles SEB-250-3P-US

GUDID 20850002391019

Sebacia Microparticles ia a medical device consisting of engineered gold microparticles suspension intended for single use topical application. Sebacia Microparticles are designed to work as an accessory to a commercially available medically approved 1064nm laser by preferentially absorbing the light and converting it to heat, creating a focal thermal effect to the follicle and sebaceous gland for the treatment of acne vulgaris.

SEBACIA, INC.

Photothermal therapy gel

• Primary Device ID: 20850002391019
• NIH Device Record Key: 2eb8bdc9-8f72-4ac7-9d34-430f7a1956aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sebacia Microparticles
• Version Model Number: SEB-250-3P-US
• Catalog Number: SEB-250-3P-US
• Company DUNS: 963219600
• Company Name: SEBACIA, INC.
• Device Count: 9
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 6788121138
• Email: richard@sebacia.com

Device Dimensions

• Total Volume: 3 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10850002391111 [Unit of Use]
GS1	20850002391019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181518

FDA Product Code

• QCY: Laser Absorbing Particles

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: 2020-06-29
• Device Publish Date: 2020-06-19