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Plastic Optical Lens M-110

by U-Molde Systems, Inc. 510(k)

Active United States

510(k) K834261

Overview

The device is a plastic optical lens, specifically the PLASTIC OPTICAL LENS M-110, as identified in the device name and specifications. It is classified under the ophthalmic medical specialty and was determined to be substantially equivalent to a predicate device through the FDA 510(k) process.

The device received FDA 510(k) clearance under K834261 on March 16, 1984, with a traditional clearance type and decision code SESE. It is manufactured by U-Molde Systems, Inc. and is associated with product code HQC and regulation number 886.4670.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK834261 Date16 Mar 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HQC
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the PLASTIC OPTICAL LENS M-110 and what is it used for?

    The PLASTIC OPTICAL LENS M-110 is an ophthalmic medical device classified under the ophthalmic specialty. It is a plastic optical lens intended for use in eye care applications, as indicated by its classification and regulatory pathway under product code HQC and regulation number 886.4670.

  • How is the device supplied and is it sterile?

    The device data does not specify the supply format, packaging, or sterility status. These details would typically be found in the manufacturer’s product labeling or instructions for use, which are not included in the provided regulatory registry information.

  • Is the PLASTIC OPTICAL LENS M-110 single-use or reusable?

    The device data does not indicate whether the lens is single-use or reusable. Such information would be determined by the manufacturer’s intended use instructions and sterilization validation, which are not detailed in the regulatory submission record provided.

  • What sizes or models are available for this lens?

    Only one model, the PLASTIC OPTICAL LENS M-110, is identified in the device data. No additional sizes, variants, or model numbers are listed, suggesting this may be a single configuration within the product line.

  • How should the device be stored?

    Storage conditions for the PLASTIC OPTICAL LENS M-110 are not specified in the available data. Proper storage requirements would typically be provided by the manufacturer in the product labeling and should be followed to maintain device integrity.