HYPERION Arm

GUDID 08800035500429

Dermatological solid-state laser system

Primary Device ID	08800035500429
NIH Device Record Key	9fbc6e0e-958b-4e1b-a50f-95c0b9b17f92
Commercial Distribution Status	In Commercial Distribution
Brand Name	HYPERION Arm
Version Model Number	HYPERION Arm
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

Handling Environment Humidity

Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Issuing Agency	Device ID
GS1	08800035500429 [Primary]

GEX	Powered Laser Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	false