SANO

GUDID 06973511890009

The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types. There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration.

Beijing Sano Lasers S&T Development Co., Ltd.

Dermatological diode laser system

• Primary Device ID: 06973511890009
• NIH Device Record Key: af49ccf3-45fc-4c47-a485-1d1b12ecac9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SANO
• Version Model Number: P-808, P-808L, P-808S, P-808W
• Company DUNS: 414243850
• Company Name: Beijing Sano Lasers 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: true
• Serial Number: true
• 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	06973511890009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191970

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: 2024-05-23
• Device Publish Date: 2024-05-15

On-Brand Devices [SANO]

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• 06973511890061: The proposed device is a type of the most advanced electromagnetic,non-invasive treatment machin
• 06973511890009: The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended fo
• 06973511890108: CO2 laser is monochromatic light with strong penetration and precise focusing; When a continuous