Product Classification

• Device: fat reducing low level laser
• Regulation Description: Low level laser system for aesthetic use
• Definition: Non-invasive reduction in fat layer for body contouring
• Physical State: laser system that emits laser energy in the red spectrum
• Technical Method: use of low level laser energy to create pores in adipocyte cells to release lipoproteins
• Target Area: adipocyte cells within the fat layer of the body, this could include wasit, thighs, abdomin, hips, etc...
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: OLI
• Premarket Review: General Surgery Devices (DHT4A); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 878.5400
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 12-242 IEC 60601-2-57 Edition 1.0 2011-01
  Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
• 12-355 IEC 60601-2-57 Edition 2.0 2023-07
  Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use

Guidance Document

• Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use - Guidance for Industry and FDA Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc