SANO

GUDID 06973511890108

CO2 laser is monochromatic light with strong penetration and precise focusing; When a continuous laser beam with a certain energy irradiates biological tissue, the instantaneous high temperature causes photo induced solidification and photo induced vaporization to irradiated tissue. With modulation pulse mode of CO2 laser, treatment effect can be achieved by control of laser emission frequency. After choosing laser Power, despite the frequency of laser emission,the laser is continuously output at a fixed interval Time of 1 ms. Changes in frequency doesn't affect Interval Time. Such design is very effective for treating warts and moles. For cutting, it works in pulse mode, which causes lighter wound, and the heat-affected area looks much better than that of continuous working mode.

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

Dermatological carbon dioxide laser system

• Primary Device ID: 06973511890108
• NIH Device Record Key: 2e49c95d-1ae0-4b69-b961-be9088a70d62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SANO
• Version Model Number: SHE-LSP003-1
• 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	06973511890108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242941

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: 2025-02-18
• Device Publish Date: 2025-02-10

On-Brand Devices [SANO]

• 06973511890092: The proposed device is a type of the most advanced electromagnetic,non-invasive treatment machin
• 06973511890085: The proposed device is a type of the most advanced electromagnetic,non-invasive treatment machin
• 06973511890078: Cryojet Plus is intended to minimize pain and thermal injury during laser and dermatological tre
• 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