VeinGogh

GUDID 86573000021011

VeinGogh electrocoagulation for aesthetic applies RF energy for treatment of lower limb spider vein or Telangiectasias. The device is aproved for use

AP MEDESTHETICS, INC.

Radio-frequency ablation system generator Radio-frequency ablation system generator

• Primary Device ID: 86573000021011
• NIH Device Record Key: 6fea75a6-e192-4619-a4cd-09c725907b0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VeinGogh
• Version Model Number: 101
• Company DUNS: 056296605
• Company Name: AP MEDESTHETICS, INC.
• 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: true
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	86573000021011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112334

FDA Product Code

• ONQ: Electrosurgical Coagulation For Aesthetic

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: 2016-12-22

Devices Manufactured by AP MEDESTHETICS, INC.

• 28657300002201 - Bristle needles: 2020-05-01 The single piece device is a plastic handle fused to a stainless-steel needle, insulated to the tip. The other end of the plast
• 18657300002204 - Bristle needles: 2020-05-01 The single piece device is a plastic handle fused to a stainless-steel needle, insulated to the tip. The other end of the plast
• 86573000022001 - Bristle needles: 2019-02-18 The single piece device is a plastic handle fused to a stainless-steel needle, insulated to the tip. The other end of the plast
• 86573000021011 - VeinGogh: 2018-07-06VeinGogh electrocoagulation for aesthetic applies RF energy for treatment of lower limb spider vein or Telangiectasias. The device is aproved for use
• 86573000021011 - VeinGogh: 2018-07-06 VeinGogh electrocoagulation for aesthetic applies RF energy for treatment of lower limb spider vein or Telangiectasias. The dev