Body Shape

GUDID 07290016727036

Exercise skin muscle equipment

ACTIVE OPTICAL SYSTEMS LTD

Multi-modality skin surface treatment system

• Primary Device ID: 07290016727036
• NIH Device Record Key: fc616b55-6b2c-418d-b2dc-cfa379f574cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Body Shape
• Version Model Number: RF-311N
• Company DUNS: 533637385
• Company Name: ACTIVE OPTICAL SYSTEMS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016727036 [Primary]

FDA Product Code

• BXB: Exerciser, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-09

Devices Manufactured by ACTIVE OPTICAL SYSTEMS LTD

• 07290016727012 - Spirit: 2018-07-06 Hair Removal Laser
• 07290016727029 - Spirit: 2018-07-06 Hair Removal Laser
• 07290016727043 - Extra: 2018-07-06 Hair removal device
• 07290016727050 - Sheerwave: 2018-07-06 Hair Removal device
• 07290016727067 - Optima: 2018-07-06 Hair removal device
• 07290016727081 - Crystal: 2018-07-06 Hair Removal Device
• 07290016727036 - Body Shape: 2018-03-29Exercise skin muscle equipment
• 07290016727036 - Body Shape: 2018-03-29 Exercise skin muscle equipment
• 07290016727074 - Top Epil Classic: 2018-03-29 Epilation device