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FLARE Single-Use Surgical Laser Fiber

by Realton (Suzhou) Medical Technology Co., Ltd.

510(k) K202702

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 NumberK202702 Date26 Feb 2021ClearedStatusActive

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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 FLARE Single-Use Surgical Laser Fiber is a device designed to deliver laser radiation to target tissue when used with compatible surgical lasers with operational wavelengths between 532 nm-2140 nm and equipped with SMA 905 compatible connector. It is intended for use in general surgical applications for both open and laparoscopic procedures.

This device is supplied as a single-use product and requires appropriate storage conditions. The FLARE Single-Use Surgical Laser Fiber has received FDA 510(k) clearance with the K202702 reference number and is classified under product code GEX. It is manufactured by Realton (Suzhou) Medical Technology Co., Ltd.

Other devices from Realton (Suzhou) Medical Technology Co., Ltd.

Questions

AI-generated answers, 22 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 is the FLARE Single-Use Surgical Laser Fiber used for?

    The FLARE Single-Use Surgical Laser Fiber is designed to deliver laser radiation to target tissue during general surgical applications, including both open and laparoscopic procedures, when used with compatible surgical lasers.

  • What lasers is the FLARE Single-Use Surgical Laser Fiber compatible with?

    This fiber is compatible with surgical lasers that have operational wavelengths between 532 nm-2140 nm and are equipped with SMA 905 compatible connectors.

  • Is the FLARE Single-Use Surgical Laser Fiber reusable?

    No, the FLARE Single-Use Surgical Laser Fiber is supplied as a single-use product and should not be reused. It requires appropriate storage conditions before use.

  • What regulatory clearance has the FLARE Single-Use Surgical Laser Fiber received?

    The FLARE Single-Use Surgical Laser Fiber has received FDA 510(k) clearance with reference number K202702 and is classified under product code GEX.