PALLAS User Manual

GUDID 08800035500917

PALLAS User Manual

Laseroptek Co.,Ltd

Dermatological excimer laser system

• Primary Device ID: 08800035500917
• NIH Device Record Key: e3881a71-40b0-4069-8731-12f4eb2acda3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALLAS User Manual
• Version Model Number: PALLAS User Manual
• 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

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800035500917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191501

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: 2020-02-18
• Device Publish Date: 2020-02-10

On-Brand Devices [PALLAS User Manual]

• 08800035500917: PALLAS User Manual
• 08800035501143: PALLAS User Manual (Rev.3)