Primary Device ID | 03760313461017 |
NIH Device Record Key | 58f9eb47-b6ac-4b9a-91dd-88f5d58d441d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EXCI308 by Aerolase |
Version Model Number | EIPL-100 |
Catalog Number | EIPL-PRD-K01-exci308 |
Company DUNS | 266012441 |
Company Name | CLARTEIS |
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 | false |
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 |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03760313461017 [Primary] |
FTC | Light, Ultraviolet, Dermatological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-06-21 |
Device Publish Date | 2022-06-13 |
03760313461017 - EXCI308 by Aerolase | 2022-06-21Exci308® 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 Aerolase | 2022-06-21 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EXCI308 BY AEROLASE 97370221 not registered Live/Pending |
AEROLASE CORPORATION 2022-04-19 |