EpilMe System

GUDID 00850017374201

Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialties of general and plastic surgery, and dermatology.

NEAUVIA NORTH AMERICA, INC.

Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system

• Primary Device ID: 00850017374201
• NIH Device Record Key: b55d3acf-cdad-409c-827d-fdc3691e5a12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EpilMe System
• Version Model Number: 300-1601
• Company DUNS: 117030786
• Company Name: NEAUVIA NORTH AMERICA, 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: 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	00850017374201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213261

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: 1
• Public Version Date: 2022-10-11
• Device Publish Date: 2022-10-03

Devices Manufactured by NEAUVIA NORTH AMERICA, INC.

• 00850017374188 - LaserMe: 2023-08-23 The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedure
• 00850017374201 - EpilMe System: 2022-10-11Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialties of general and plastic surgery, and dermatology.
• 00850017374201 - EpilMe System: 2022-10-11 Laser EpilME with EpilME applictor is indicated for use in surgical and aesthetic applications in the medical specialties of gen
• 00850017374218 - EpilMe Applicator: 2022-10-11 Handpiece applicator for EpilMe System
• 00850017374126 - Sectum System: 2021-10-05
• 00850017374133 - Sectum Precise (Face) Applicator: 2021-10-05
• 00850017374140 - Sectum Body Applicator: 2021-10-05
• 00850017374157 - Sectum Foot Switch: 2021-10-05 Foot switch for the Sectum System
• 00850017374164 - Sectum Cable Body Applicator: 2021-10-05