SUPERLASER

GUDID 06973537443005

Beijing Superlaser Technology Co., Ltd.

Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator Multi-modality skin surface treatment system generator

• Primary Device ID: 06973537443005
• NIH Device Record Key: 3ec8933a-1c2a-48d6-866f-234ddc068351
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPERLASER
• Version Model Number: SL-NY602
• Company DUNS: 547486679
• Company Name: Beijing Superlaser Technology 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: false
• 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	06973537443005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193464

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: 2020-08-17
• Device Publish Date: 2020-08-08

On-Brand Devices [SUPERLASER]

• 06973537444002: SL-LC01
• 06973537443005: SL-NY602
• 06973537442008: AAD Dual Light
• 06973537441001: SL-HR10