HELIOS IV 785 DIA FX 785 s Handpiece

GUDID 08800035501501

HELIOS IV 785 DIA FX 785 s Handpiece

Laseroptek Co.,Ltd

General/multiple surgical frequency-doubled solid-state laser system

• Primary Device ID: 08800035501501
• NIH Device Record Key: 429905cd-0473-4931-ac8a-a538ebefe149
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELIOS IV 785 DIA FX 785 s Handpiece
• Version Model Number: HELIOS IV 785 DIA FX 785 s Handpiece
• Company DUNS: 689856875
• Company Name: Laseroptek 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800035501501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212663

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: 2022-06-28
• Device Publish Date: 2022-06-20

Devices Manufactured by Laseroptek Co.,Ltd

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• 08800035501877 - HELIOS 785 Pico Arm: 2025-02-26 HELIOS 785 Pico (1754V2) Arm
• 08800035501884 - HELIOS 785 Pico Zoom Handpiece: 2025-02-26 HELIOS 785 Pico (1754V2) Zoom Handpiece
• 08800035501891 - HELIOS 785 Pico Zoom Collimator Handpiece: 2025-02-26 HELIOS 785 Pico (1754V2) Zoom Collimator Handpiece
• 08800035501907 - HELIOS 785 Pico 1064 FX Handpiece: 2025-02-26 HELIOS 785 Pico (1754V2) 1064 FX Handpiece
• 08800035501914 - HELIOS 785 Pico 785 Zoom Handpiece: 2025-02-26 HELIOS 785 Pico (1754V2) 785 Zoom Handpiece
• 08800035501921 - HELIOS 785 Pico 785 Collimator Handpiece: 2025-02-26 HELIOS 785 Pico (1754V2) 785 Collimator Handpiece
• 08800035501938 - HELIOS 785 Pico DIA FX 785 s Handpiece: 2025-02-26 HELIOS 785 Pico (1754V2) DIA FX 785 s Handpiece