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Refractec MCS-100

by Refractec, Inc.

510(k) K980522

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)SESU Traditional NumberK980522 Date22 Jul 1998ClearedStatusActive

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  • Withdrawn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
HQR
Device Class
Class II
Regulation
21 CFR Part 886.4100
Advisory Committee
Ophthalmic
FDA Decision
SESU

Overview

AI-generated summary, 19 Sep 2026

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

The Refractec MCS-100 is an Apparatus, Cautery, Radiofrequency, AC-Powered, designed for ophthalmic procedures. It delivers controlled radiofrequency energy to perform precise tissue cauterization, aiding in surgical applications within the eye.

This device is supplied as a reusable medical instrument, intended for use in sterile ophthalmic settings. It operates under FDA clearance (510K, K980522) and falls under product code HQR, classified as a Class 2 device. Storage and handling must comply with standard ophthalmic surgical protocols to maintain sterility and functionality.

Other devices from Refractec, Inc.

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of ophthalmic procedures is the Refractec MCS-100 designed to assist with, and how does it achieve this?

    The Refractec MCS-100 is specifically designed for ophthalmic procedures that require precise tissue cauterization. It delivers controlled radiofrequency energy to safely and accurately seal or coagulate tissue during surgery, helping to reduce bleeding and improve surgical outcomes in eye-related procedures.

  • Is the Refractec MCS-100 a single-use or reusable device, and what considerations should be taken for its maintenance?

    The Refractec MCS-100 is a reusable medical instrument, meaning it is intended for repeated use in sterile ophthalmic settings. To maintain sterility and functionality, it must be cleaned, disinfected, and stored according to standard ophthalmic surgical protocols after each use, ensuring compliance with regulatory and clinical best practices.

  • How is the Refractec MCS-100 powered, and what regulatory pathway does it follow for market authorization?

    The Refractec MCS-100 is an AC-powered device, meaning it requires an electrical outlet to operate. It follows the traditional FDA 510(k) clearance pathway, with clearance under the product code HQR, and is classified as a Class 2 device, indicating it has undergone rigorous review by the FDA’s Ophthalmic Advisory Committee.

  • What storage and handling guidelines should be followed to ensure the device remains functional and sterile?

    Since the Refractec MCS-100 is reusable and intended for sterile ophthalmic use, it must be stored and handled in accordance with standard surgical protocols to preserve sterility and functionality. This includes proper cleaning, sterilization, and storage in a clean, dry environment to prevent contamination or damage before and after use.