EXCI308 by Aerolase EIPL-PRD-K01-exci308

GUDID 03760313461017

Exci308® by Aerolase This medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. Excimer light source, wavelength 308nm, optical power 2500 mW.

CLARTEIS

Ultraviolet phototherapy unit, professional
Primary Device ID03760313461017
NIH Device Record Key58f9eb47-b6ac-4b9a-91dd-88f5d58d441d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXCI308 by Aerolase
Version Model NumberEIPL-100
Catalog NumberEIPL-PRD-K01-exci308
Company DUNS266012441
Company NameCLARTEIS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS103760313461017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTCLight, Ultraviolet, Dermatological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-21
Device Publish Date2022-06-13

Devices Manufactured by CLARTEIS

03760313461017 - EXCI308 by Aerolase2022-06-21Exci308® by Aerolase This medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. Excimer light source, wavelength 308nm, optical power 2500 mW.
03760313461017 - EXCI308 by Aerolase2022-06-21 Exci308® by Aerolase This medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, an
03760313461000 - Exciplex®2020-09-17 Exciplex® set - USA This medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and

Trademark Results [EXCI308 by Aerolase]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXCI308 BY AEROLASE
EXCI308 BY AEROLASE
97370221 not registered Live/Pending
AEROLASE CORPORATION
2022-04-19

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