SurgiLight 1470 Diode Laser System

GUDID 06976712970235

Micro-Energy Medical Technology Co., Ltd

General/multiple surgical diode laser system

• Primary Device ID: 06976712970235
• NIH Device Record Key: b188a7d8-8770-4b37-a165-1936abf4e457
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiLight 1470 Diode Laser System
• Version Model Number: Halo
• Company DUNS: 620289544
• Company Name: Micro-Energy Medical Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	06976712970235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251049

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: 2025-12-25
• Device Publish Date: 2025-12-17

Devices Manufactured by Micro-Energy Medical Technology Co., Ltd

• 06976712970242 - Halo Sterile Single-use Radial Fiber: 2025-12-29
• 06976712970259 - Halo Sterile Single-use Radial Fiber: 2025-12-29
• 06976712970266 - Halo Sterile Single-use Radial Fiber: 2025-12-29
• 06976712970273 - Halo Sterile Single-use Radial Fiber: 2025-12-29
• 06976712970235 - SurgiLight 1470 Diode Laser System: 2025-12-25
• 06976712970235 - SurgiLight 1470 Diode Laser System: 2025-12-25