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 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

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	03760313461017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191086

FDA Product Code

• FTC: Light, Ultraviolet, Dermatological

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: 2022-06-21
• Device Publish Date: 2022-06-13

Devices Manufactured by CLARTEIS

• 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