SR515 applicator

GUDID 07290016540505

• Treatment of benign pigmented epidermal and cutaneous lesions including: dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, n

VENUS CONCEPT LTD

Light-energy skin surface treatment system applicator

• Primary Device ID: 07290016540505
• NIH Device Record Key: e1219314-8ce7-42aa-87e5-f06ccd604f09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SR515 applicator
• Version Model Number: AS120033
• Company DUNS: 533127663
• Company Name: VENUS CONCEPT 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016540390 [Primary]
GS1	07290016540505 [Package]; Contains: 07290016540390; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153717

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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: 2016-09-24

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