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Inpulse Dental Laser

by Incisive, LLC

510(k) K011423

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 NumberK011423 Date7 Aug 2001ClearedStatusActive

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  • Withdrawn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, 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 InPulse Dental Laser InPulse Touch 120 is a diode laser device (Product Code: GEX) designed for dental procedures. It delivers controlled laser energy for soft tissue applications, including gingival surgery, periodontal therapy, and tissue sculpting. Its precision wavelength facilitates minimally invasive treatments, reducing patient discomfort and promoting faster healing. The device is classified under the General, Plastic Surgery advisory committee category for regulatory review.

This laser is supplied as a reusable medical device, intended for use in dental clinics and oral surgery settings. It operates with a non-sterile handpiece that requires sterilization between patient uses, adhering to standard dental infection control protocols. The InPulse Touch 120 is FDA-cleared under a 510(k) submission (K011423) as substantially equivalent to a predicate device, with no current commercial distribution status. Storage and handling follow manufacturer guidelines to maintain device integrity and performance.

Other devices from Incisive, LLC

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 InPulse Touch 120 Dental Laser used for?

    The InPulse Touch 120 is a diode laser designed specifically for dental soft tissue applications. It is used in procedures such as gingival surgery, periodontal therapy, and tissue sculpting. Its controlled laser energy allows for minimally invasive treatments, minimizing patient discomfort and accelerating recovery times.

  • Is the InPulse Touch 120 Dental Laser reusable or single-use?

    The InPulse Touch 120 is a reusable medical device. However, its non-sterile handpiece must be sterilized between uses to comply with dental infection control protocols. This ensures safe and hygienic operation in clinical environments.

  • How should the InPulse Touch 120 Dental Laser be stored?

    Storage and handling of the InPulse Touch 120 must follow the manufacturer’s guidelines to preserve its performance and integrity. Proper storage conditions help maintain the device’s functionality and ensure it remains ready for use in dental procedures.

  • What regulatory pathway was followed for the InPulse Touch 120?

    The InPulse Touch 120 received FDA clearance through a 510(k) submission (K011423), demonstrating it is substantially equivalent to a predicate device. The device was reviewed under the General, Plastic Surgery advisory committee category and classified under Product Code GEX.

  • Does the InPulse Touch 120 have commercial distribution?

    As of current records, the InPulse Touch 120 has no commercial distribution status, despite its FDA clearance. This means it is not actively sold or marketed for use in dental clinics at this time.