LED Spectrum therapy instrument

GUDID 06976264730035

SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD

Blue/red/infrared phototherapy lamp

• Primary Device ID: 06976264730035
• NIH Device Record Key: 1cb5fe9e-dec8-4d11-92a2-9d786737ba6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LED Spectrum therapy instrument
• Version Model Number: PDT-J
• Company DUNS: 706040997
• Company Name: SHENZHENSHI SINCOHEREN S&T DEVELOPMENT 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976264730035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231894

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: 2023-11-27
• Device Publish Date: 2023-11-17

On-Brand Devices [LED Spectrum therapy instrument]

• 06976264730066: PDT-M
• 06976264730059: PDT-L
• 06976264730042: PDT-K
• 06976264730035: PDT-J
• 06976264730028: PDT-I