F1 Diode Laser System

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

510(k) Number

K004021 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Opus Magnum Knotless Anchor With Inserter Handle

  Class II

  FDA 510(k) K042914 Active Cleared 12 Nov 2004

• Opus Magnum Implant System, Model Om-1500

  Class II

  FDA 510(k) K031083 Active Cleared 12 Jun 2003

• F1 Diode Laser System

  Class II

  FDA 510(k) K030235 Active Cleared 23 Apr 2003

• Opus Magnum Anchor & Inserter

  Class II

  FDA 510(k) K012125 Active Cleared 17 Sep 2001

• Opus Speedstitch Suture Device

  Class II

  FDA 510(k) K042031 Active Cleared 19 Oct 2004

• Smartstitch M-Connector, Model Om-8005; Smartstitch Actuation Handle, Model Om-8500; and Smartstitch Suture Cartridge

  Class II

  FDA 510(k) K023843 Active Cleared 14 Feb 2003

See all devices from Opus Medical, Inc. →

• What types of surgical procedures is the F1 Diode Laser System primarily used for, and why is it considered suitable for these applications?

  The F1 Diode Laser System is designed for general and plastic surgery procedures, as well as dermatological applications. It is suitable for these uses because it delivers controlled light energy to perform tissue ablation, coagulation, or vaporisation with precision, minimizing thermal damage—a critical factor in delicate surgical environments where tissue integrity must be preserved.

• Is the F1 Diode Laser System intended for single-use or reusable applications, and what sterilization requirements apply?

  The F1 Diode Laser System is a reusable medical device, meaning it must undergo proper sterilization between uses to ensure safety and efficacy. Since it is not single-use, adherence to strict sterilization protocols is essential to maintain its performance and prevent contamination in clinical settings.

• What safety considerations must be taken into account when using the F1 Diode Laser System in a clinical environment?

  The F1 Diode Laser System is not MRI-safe, so it must only be used in environments where MRI compatibility is not required. Additionally, it must be operated in compliance with laser safety regulations to protect both patients and staff, as it emits controlled light energy for surgical procedures.

• How was the F1 Diode Laser System evaluated for regulatory approval, and what does its classification under product code GEX indicate?

  The F1 Diode Laser System was evaluated through an FDA 510(k) clearance process, specifically under the General, Plastic Surgery advisory committee (SU). Its classification under product code GEX indicates it is intended for surgical applications involving tissue ablation, coagulation, or vaporisation, aligning with its use in general, plastic, and dermatological surgeries.