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ClearPath DS-120(R) Lens Fluorescence Biomicroscope

by Freedom Meditech, Inc.

510(k) K112880

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 NumberK112880 Date31 Jan 2013ClearedStatusActive

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  • Withdrawn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
MYC
Device Class
Class II
Regulation
21 CFR Part 886.1570
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The ClearPath DS-120(R) Lens Fluorescence Biomicroscope is a specialized ophthalmic device classified as an ophthalmoscope, laser, scanning instrument. It is designed to detect autofluorescence in the crystalline lens, utilizing an eye-safe blue LED illumination system to examine ocular structures with precision. This device aids in the assessment of lens integrity and potential pathological changes under controlled lighting conditions.

This biomicroscope is intended for use in clinical ophthalmic settings and has received FDA 510(k) clearance under the product code MYC, categorized as Class II with special controls. It is supplied as a reusable medical device and adheres to optical radiation safety limits. The device is regulated under the Federal Food, Drug, and Cosmetic Act, with its specifications and safety validated through the FDA’s review process. No additional sterility or single-use requirements are specified in the regulatory data.

Questions

AI-generated answers, 1 Oct 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 ClearPath DS-120(R) Lens Fluorescence Biomicroscope used for?

    This device is designed to detect autofluorescence in the crystalline lens, allowing clinicians to examine ocular structures with precision under controlled lighting conditions. The eye-safe blue LED illumination helps identify potential pathological changes in the lens, supporting early assessment of lens integrity.

  • Is the ClearPath DS-120(R) Lens Fluorescence Biomicroscope reusable or single-use?

    The ClearPath DS-120(R) is supplied as a reusable medical device. It is not classified as single-use, and no additional sterility requirements are specified beyond standard reusable medical device protocols. The device adheres to optical radiation safety limits to ensure safe repeated use.

  • What regulatory approval does the ClearPath DS-120(R) Lens Fluorescence Biomicroscope hold?

    The device has received FDA 510(k) clearance under product code MYC, classified as Class II with special controls. It is regulated under the Federal Food, Drug, and Cosmetic Act, with its safety and performance validated through the FDA’s review process.

  • How does the blue LED illumination system contribute to its functionality?

    The eye-safe blue LED illumination system in the ClearPath DS-120(R) provides precise, controlled lighting to enhance visualization of autofluorescence in the crystalline lens. This feature allows clinicians to better assess lens integrity and detect potential pathological changes without exposing patients to harmful radiation.

  • What clinical settings is the ClearPath DS-120(R) intended for?

    This biomicroscope is specifically intended for use in clinical ophthalmic settings. Its specialized design and functionality make it suitable for ophthalmologists and eye care professionals who require detailed examination of the lens and ocular structures for diagnostic purposes.