capillus

GUDID 06950940802506

Shenzhen Osto Technology Co.,Ltd.

Acupuncture electrical stimulation system

• Primary Device ID: 06950940802506
• NIH Device Record Key: 17035fba-4a12-4822-9c01-d427dde4cbee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: capillus
• Version Model Number: AST-805A
• Company DUNS: 528161684
• Company Name: Shenzhen Osto Technology Co.,Ltd.
• Device Count: 501
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	06950940802490 [Primary]
GS1	06950940802506 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213056

FDA Product Code

• OLP: Over-The-Counter Powered Light Based Laser For Acne

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: 2025-03-24
• Device Publish Date: 2025-03-15

On-Brand Devices [capillus]

• 06950940802278: AST-804
• 06950940802506: AST-805A