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ReBorn 1050nm Laser

by Lightfective, Ltd. Israel EUDAMED510(k)

510(k) K233962

Product code PKT

Overview

The ReBorn 1050nm Laser is a Class II medical device classified under Laser for Disruption of Adipocyte Cells for Aesthetic Use, designed for non-invasive body contouring procedures. It employs a 1050nm wavelength laser to selectively target and disrupt adipose (fat) cells, promoting localized fat reduction without surgical intervention. This technology is intended for aesthetic applications in general and plastic surgery settings, adhering to regulatory standards for laser-based cosmetic treatments.

The device is supplied as a reusable medical instrument, intended for use in controlled clinical environments such as surgical or aesthetic clinics. It operates under FDA 510(k) clearance (K233962) and EU MDR compliance, with regulatory classification under 878.5400 for laser devices. Sterility and maintenance protocols must follow manufacturer guidelines to ensure safe, repeated use, and its design adheres to MRI safety standards for non-ferromagnetic components. Storage and handling require adherence to standard laser device precautions, including protection from moisture and physical damage.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK233962 Date16 Apr 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

Full name
ReBorn (1050nm)
510(k) Number
FDA Product Code
PKT
FDA applicant
Lightfective , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.5400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Lightfective, Ltd.

Questions

  • What clinical settings is the ReBorn (1050nm) Laser intended for use in, and how does its classification support its application?

    The ReBorn (1050nm) Laser is designed for use in controlled clinical environments such as surgical or aesthetic clinics, specifically for non-invasive body contouring procedures. Its classification as a Class II medical device under the product code PKT (Laser for Disruption of Adipocyte Cells for Aesthetic Use) aligns with its intended use in general and plastic surgery settings, where aesthetic treatments are performed. The device’s FDA 510(k) clearance (K233962) and EU MDR compliance further validate its regulatory pathway for aesthetic laser applications.

  • Is the ReBorn (1050nm) Laser single-use or reusable, and what maintenance or sterility requirements apply?

    The ReBorn (1050nm) Laser is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings. Sterility and maintenance must follow the manufacturer’s guidelines to ensure safe operation. Since it is reusable, proper cleaning, disinfection, and storage protocols are critical to prevent contamination and maintain performance. The device’s design also adheres to MRI safety standards, ensuring non-ferromagnetic components for compatibility with imaging environments.

  • What wavelength does the ReBorn (1050nm) Laser use, and how does this technology work for fat reduction?

    The ReBorn (1050nm) Laser employs a 1050nm wavelength, which selectively targets and disrupts adipose (fat) cells during non-invasive body contouring procedures. This wavelength is designed to promote localized fat reduction by breaking down fat cells without damaging surrounding tissues, making it suitable for aesthetic applications in plastic and general surgery clinics. The technology avoids surgical intervention while achieving visible contouring results.

  • How should the ReBorn (1050nm) Laser be stored, and what precautions should be taken to ensure its longevity and safety?

    The ReBorn (1050nm) Laser requires storage in accordance with standard laser device precautions, including protection from moisture and physical damage. Since it is a reusable instrument, it must be stored in a clean, dry environment when not in use, following the manufacturer’s instructions for maintenance. Proper handling ensures the device remains functional and safe for repeated clinical applications, while also preserving its MRI-compatible design.

  • What regulatory pathways does the ReBorn (1050nm) Laser follow, and how does this affect its availability in different markets?

    The ReBorn (1050nm) Laser has obtained FDA 510(k) clearance (K233962) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. It also complies with EU MDR (Medical Device Regulation), ensuring its availability in European markets. These regulatory approvals confirm its safety and effectiveness for non-invasive body contouring in aesthetic and plastic surgery settings, supporting its use in both the U.S. and EU.

Properties & raw data

Show properties, registry sources and raw records

Sources (2)

  • FDA 510(k) K233962 24 fields · synced 22 Oct 2026
  • EUDAMED 1 fields · synced 19 May 2026