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Precept Micro-Gard Laser Mask

by Mars White Knight

510(k) K891409

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 NumberK891409 Date7 Apr 1989ClearedStatusActive

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  • Withdrawn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
FXX
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Precept Micro-Gard Laser Mask is a surgical mask designed for use during laser procedures. It is intended to provide protection during medical and plastic surgery applications where laser technology is employed.

This device is supplied as non-sterile and is classified as a Class II medical device with product code FXX. It received FDA 510(k) clearance with number K891409 on April 7, 1989, as substantially equivalent to predicate devices.

Questions

AI-generated answers, 6 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 Precept Micro-Gard Laser Mask used for?

    The Precept Micro-Gard Laser Mask is a surgical mask specifically designed for use during laser procedures in medical and plastic surgery applications to provide appropriate protection.

  • Is the Precept Micro-Gard Laser Mask sterile or single-use?

    This device is supplied as non-sterile and is classified as a Class II medical device. The description does not specify whether it is single-use or reusable, so users should follow manufacturer instructions for proper usage.

  • What regulatory approvals does the Precept Micro-Gard Laser Mask have?

    The Precept Micro-Gard Laser Mask received FDA 510(k) clearance with number K891409 on April 7, 1989, and is classified as substantially equivalent to predicate devices. It is classified under product code FXX.

  • How is the Precept Micro-Gard Laser Mask supplied?

    The device is supplied as non-sterile. The description does not specify packaging details or the number of masks per package, so users should contact the manufacturer for specific supply information.