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Newlensco Classic Series Model MP-2410 Tier B

by Newlensco

PMA P870075

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P870075↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP870075 Date13 Sep 1991ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Newlensco Classic Series(Tm) Model Mp-2410 Tier B
Generic Name
intraocular lens
PMA Number
FDA Product Code
HQL
Device Class
Class III
Regulation
21 CFR Part 886.3600
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S003 (Normal 180 Day Track)

Overview

AI-generated summary, 18 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 Newlensco Classic Series Model MP-2410 Tier B is an intraocular lens designed for implantation in the eye to replace the natural lens. It is classified as a Class III medical device under FDA regulation 886.3600 and is intended for use in ophthalmic surgical procedures.

This device is supplied as a sterile, single-use implant and is manufactured by Newlensco in Monrovia, California. It received FDA Premarket Approval (PMA) on September 13, 1991, under application number P870075, with supplement S003 documenting design and material changes. The lens is not MRI conditional unless explicitly stated, and no reusability or size specifications are provided in the data.

Questions

AI-generated answers, 18 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 regulatory status of the Newlensco Classic Series Model MP-2410 Tier B?

    The device received FDA Premarket Approval (PMA) on September 13, 1991, under application number P870075, as indicated by the decision code APPR and decision date in the data. This approval is specific to this model and its design as documented in supplement S003.

  • Is the Newlensco Classic Series Model MP-2410 Tier B a reusable device?

    The device data does not specify reusability. However, as an intraocular lens implanted during surgery, it is intended for single-use implantation and is not designed for explantation and reuse in another patient. Intraocular lenses are universally single-use implants by design and regulatory expectation.

  • What medical specialty is the Newlensco Classic Series Model MP-2410 Tier B associated with?

    The device is associated with the ophthalmic medical specialty, as indicated by both the advisory committee description and medical specialty description fields in the specifications, which state 'Ophthalmic'. The product code HQL also corresponds to intraocular lenses in ophthalmic use.