Sectum System

GUDID 00850017374126

NEAUVIA NORTH AMERICA, INC.

Radio-frequency skin contouring system

• Primary Device ID: 00850017374126
• NIH Device Record Key: e0b5d605-57c1-428d-9a7b-db65d2e38956
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sectum System
• Version Model Number: 100-1301
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017374126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202780

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2021-10-05
• Device Publish Date: 2021-09-27

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: 2022-10-11 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
• 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