cosytime

GUDID 16977603320037

Ningbo Dechang Electrical Machinery Made Co.,Ltd.

Blue/red/infrared phototherapy lamp

• Primary Device ID: 16977603320037
• NIH Device Record Key: 0b4e9d14-761e-440c-8438-13b8d2bc6894
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cosytime
• Version Model Number: RT01
• Company DUNS: 544874472
• Company Name: Ningbo Dechang Electrical Machinery Made Co.,Ltd.
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06977603320030 [Primary]
GS1	16977603320037 [Package]; Contains: 06977603320030; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242068

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: 2025-12-08
• Device Publish Date: 2025-11-28