eCO2

GUDID 8809447651590

eCO2 PLUS(USA) body (eCO2 Plus laser system)

Lutronic Corporation

Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system Dermatological carbon dioxide laser system

• Primary Device ID: 8809447651590
• NIH Device Record Key: 7615e660-9072-48ce-b8d0-0c05e235969c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eCO2
• Version Model Number: eCO2 PLUS(USA) body
• Company DUNS: 688282516
• Company Name: Lutronic 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: 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

Customer Support Contacts

• Phone: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com
• Phone: 215-205-2219
• Email: jvojir@lutronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809447651583 [Primary]
GS1	8809447651590 [Package]; Contains: 08809447651583; Package: carton case [1 Units]; In Commercial Distribution

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-07-26
• Device Publish Date: 2016-09-09

Devices Manufactured by Lutronic Corporation

• 08809447652191 - N/A: 2023-06-19 Metal Goggle (for patient) of Advantage/Eco2/ACTIONII/SPECTRA/CLARITY/ LASEMD/ DENTAII / PICOPLUS
• 08809447655239 - DermaV: 2022-03-07 CARTRIDGE_DermaV_2, 3, 5_7, 8_10_12, 12_14_16, 3X10 mm, FRACTIONAL
• 08809447655246 - DermaV: 2022-03-07 HANDPIECE ASSY_ST-A_GL19
• 08809447655253 - DermaV: 2022-03-07 COMPL_POLE_FIBER
• 08809447655260 - DermaV: 2022-03-07 WINDOW HOLDER ASSY_GL19
• 08809447655277 - DermaV: 2022-03-07 COMPL_BODY_ICD_S_DermaV_220V / USA / ICD
• 08809447655284 - DermaV: 2022-03-07 FOOT SWITCH_GL19
• 08809447655291 - DermaV: 2022-03-07 DermaV_MANUAL_REV00_USA