Skip to content

Mastel Laser Clean Room, Model EBS-100

by Mastel Precision Surgical Instruments, Inc.

510(k) K043494

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 NumberK043494 Date4 Oct 2005ClearedStatusActive

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  • Withdrawn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
FYD
Device Class
Class II
Regulation
21 CFR Part 878.5070
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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 Mastel Laser Clean Room, Model EBS-100, is an Apparatus, Exhaust, Surgical designed to control airborne contaminants during laser surgical procedures. It provides a contained environment to minimize particulate dispersion, ensuring a cleaner workspace for precision laser applications in general and plastic surgery settings.

This device is supplied as a reusable system intended for use in operating rooms or surgical suites. It is classified under 21 CFR 878.5070 and has received FDA 510(k) clearance (K043494) as substantially equivalent to a predicate device. The unit is not described as sterile or single-use, and its MRI safety or specific size configurations are not detailed in the regulatory submission.