GentleLase LE 10/12/15 RGD Delivery System

GUDID 00817495021867

Dermatological laser beam guiding handpiece

Primary Device ID	00817495021867
NIH Device Record Key	e29ebac1-f6ae-4eb0-b91f-35e25f4be68e
Commercial Distribution Status	In Commercial Distribution
Brand Name	GentleLase LE 10/12/15 RGD Delivery System
Version Model Number	7122-00-7551
Company DUNS	053468385
Company Name	CANDELA CORPORATION
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

Device Issuing Agency	Device ID
GS1	00817495021867 [Primary]
GS1	08174950201861 [Previous]

GEX	Powered Laser Surgical Instrument

Steralize Prior To Use	false
Device Is Sterile	false