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Chrys Model Med-Max

by California Laboratories, Inc.

510(k) K875338

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 NumberK875338 Date13 Apr 1988ClearedStatusActive

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  • Withdrawn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)

Full name
Chrys(Tm) Model Med-Max
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, 25 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 Chrys Model Med-Max is a powered laser surgical instrument. It is classified under product code GEX and falls within the medical specialties of general and plastic surgery.

This device received FDA 510(k) clearance (K875338) on April 13, 1988, from California Laboratories, Inc., and was determined to be substantially equivalent. It is intended for use in general and plastic surgery settings as a powered laser surgical instrument.

Other devices from California Laboratories, Inc.

Questions

AI-generated answers, 25 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 Chrys Model Med-Max used for?

    The Chrys Model Med-Max is a powered laser surgical instrument intended for use in general and plastic surgery settings, as specified in its FDA 510(k) clearance documentation.

  • Who manufactures the Chrys Model Med-Max and where are they located?

    The Chrys Model Med-Max is manufactured by California Laboratories, Inc., located at 5964 La Pl. Ct., Carlsbad, CA 92008, United States.

  • What regulatory pathway was used for the Chrys Model Med-Max and when was it cleared?

    The Chrys Model Med-Max received FDA 510(k) clearance under traditional review on April 13, 1988, with clearance number K875338, and was found substantially equivalent to a predicate device.