C + B Pelo 1042

GUDID B12510420

Scanned diode laser 808 nm for hair reduction

GME German Medical Engineering GmbH

Dermatological diode laser system

• Primary Device ID: B12510420
• NIH Device Record Key: ec2ebafd-ba2b-4a92-932c-10c36e47ab5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C + B Pelo
• Version Model Number: 1042
• Catalog Number: 1042
• Company DUNS: 342234451
• Company Name: GME German Medical Engineering GmbH
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 99 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 89 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B12510420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141063

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-16

Devices Manufactured by GME German Medical Engineering GmbH

• B12510700 - FlexSys: 2021-03-18 The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these
• B12510600 - TwinScan 808/755 Laser System: 2019-12-09 Scanned diode laser 808 nm and 755 nm for hair reduction
• B12510000 - ExSys 308: 2019-02-07 Excimer light 308 nm system
• B12510500 - LinScan: 2018-12-21 scanned diode laser 808 nm for hair reduction
• B12510420 - C + B Pelo: 2018-07-06Scanned diode laser 808 nm for hair reduction
• B12510420 - C + B Pelo: 2018-07-06 Scanned diode laser 808 nm for hair reduction