HYPERION Red Handpiece

GUDID 08800035500443

HYPERION Red Handpiece

Laseroptek Co.,Ltd

Dermatological solid-state laser system

• Primary Device ID: 08800035500443
• NIH Device Record Key: ad690f6c-43e8-42ff-9e15-02134c3ebe1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYPERION Red Handpiece
• Version Model Number: HYPERION Red 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800035500443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132286

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-01-12

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