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Lipofina Laser System

by Yolo Medical, Inc.

510(k) K143741

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK143741 Date24 Apr 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OLI
Device Class
Class II
Regulation
21 CFR Part 878.5400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lipofina Laser System is a Fat Reducing Low Level Laser (Device Class II), designed for non-invasive aesthetic procedures. It employs low-level laser technology to target subcutaneous fat, intended for temporary reduction in waist circumference without surgical intervention.

This device is supplied as a reusable medical system, cleared under FDA 510(k) K143741 as substantially equivalent to the i-Lipo™ System. It is intended for use in clinical settings by trained professionals, with no specific sterility requirements stated. The system operates under regulation number 878.5400 and is classified under OpenFDA product code OLI for fat reduction applications in general and plastic surgery.

Other devices from Yolo Medical, Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Lipofina Laser System primarily used for in clinical settings?

    The Lipofina Laser System is designed for non-invasive aesthetic procedures to temporarily reduce subcutaneous fat, specifically targeting waist circumference without surgery. It uses low-level laser technology to achieve this effect, making it suitable for patients seeking cosmetic fat reduction.

  • Is the Lipofina Laser System reusable or single-use, and what does that mean for maintenance?

    The Lipofina Laser System is supplied as a reusable medical device. This means it is intended for repeated use in clinical settings, but proper cleaning, maintenance, and sterilization procedures must be followed to ensure safety and functionality between uses, as no specific sterility requirements are stated in the device documentation.

  • How is the regulatory approval status of the Lipofina Laser System determined?

    The Lipofina Laser System received FDA clearance under a 510(k) submission (K143741) and was determined to be substantially equivalent to the i-Lipo™ System. This classification means it meets regulatory standards for safety and effectiveness as a Class II device, specifically for fat reduction in general and plastic surgery applications, under regulation number 878.5400.

  • What types of medical specialties are most likely to use the Lipofina Laser System?

    The Lipofina Laser System is categorized under the OpenFDA product code OLI for fat reduction, with a medical specialty description listing General and Plastic Surgery. Clinicians in these fields, particularly those specializing in cosmetic or aesthetic procedures, are the primary users of this device.