Luxscope

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

510(k) Number

K973193 ↗

FDA Product Code

HQF

Device Class

Class II

Regulation

21 CFR Part 886.4390

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Frazier Suction Tube

  Class I

  FDA 510(k) K864382 Active Cleared 14 Jan 1987

• Lutex Headlight Systems

  Class II

  FDA 510(k) K864380 Active Cleared 19 Nov 1986

• Luxtec Fiberoptic Cables

  Class I

  FDA 510(k) K864387 Active Cleared 22 May 1987

• Luxtec Aco Series 4000 Light Source

  Class II

  FDA 510(k) K890716 Active Cleared 26 Apr 1989

• Luxtec Retractors, Luxtec Specialty Retractors

  Class I

  FDA 510(k) K864384 Active Cleared 19 Nov 1986

• Luxtec Loupes for Surgical Vision

  Class I

  FDA 510(k) K864386 Active Cleared 17 Nov 1986

See all devices from Luxtec Corp. →

• Is the Luxscope designed for single-use or can it be reused in multiple procedures?

  The Luxscope is explicitly described as a reusable medical instrument, intended for use in clinical settings like ophthalmology clinics and hospitals. Since it is classified as a reusable device, it must follow proper cleaning, sterilization, and maintenance protocols to ensure safety and functionality across multiple procedures.

• What types of retinal procedures is the Luxscope primarily used for, and how does it deliver laser energy?

  The Luxscope is designed for ophthalmic laser procedures, specifically for photocoagulation—a technique used to treat conditions like diabetic retinopathy or retinal tears. It delivers controlled laser energy directly to the retina, allowing precise treatment while minimizing damage to surrounding tissue. Its classification as a Class 2 device reflects its role in moderate-risk procedures requiring careful application.

• How is the Luxscope regulated by the FDA, and what does its clearance status mean for clinicians?

  The Luxscope was cleared via the FDA’s 510(k) pathway in 1997 under product code HQF, with a Substantially Equivalent (SESE) determination. This means it was deemed comparable to a legally marketed predicate device at the time, ensuring it meets FDA safety and performance standards for ophthalmic laser use. Clinicians can rely on this clearance as evidence of regulatory review, though they should always follow manufacturer guidelines for proper operation and maintenance.

• Are there any special storage or handling requirements for the Luxscope, particularly regarding sterility or environmental conditions?

  The Luxscope is a reusable device, so sterility is maintained through proper cleaning and sterilization protocols between uses rather than pre-packaged sterility. While no explicit MRI safety or sterility specifications are noted in the data, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality. Always adhere to the manufacturer’s instructions for maintenance and storage.