Sheerwave

GUDID 07290016727050

Hair Removal device

ACTIVE OPTICAL SYSTEMS LTD

Multi-modality skin surface treatment system

• Primary Device ID: 07290016727050
• NIH Device Record Key: 1a8089d6-b842-4303-8675-3a935da0ab25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sheerwave
• Version Model Number: 360
• Company DUNS: 533637385
• Company Name: ACTIVE OPTICAL SYSTEMS LTD
• 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 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016727050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050950

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-11

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: 2018-07-06Hair 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: 2018-03-29 Exercise skin muscle equipment
• 07290016727074 - Top Epil Classic: 2018-03-29 Epilation device