Skip to content

SGP Lens

by The Lifestyle Co., Inc.

PMA P840055

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 P840055↗

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 NumberP840055 Date8 Dec 1987ApprovedStatusActive

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  • Withdrawn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
Sgp Lens(Tm)
Generic Name
Lens, contact (other material) - daily
PMA Number
FDA Product Code
HQD
Device Class
Class II
Regulation
21 CFR Part 886.5916
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S008 (THIRTY 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 SGP Lens is a daily-wear contact lens made from other materials, as classified under the nomenclature for Lens, Contact (Other Material) – Daily. These lenses are designed to correct refractive errors and provide clear vision for short-term, single-use applications, replacing daily to maintain ocular health and comfort.

Supplied as single-use, non-reusable lenses, the SGP Lens is intended for ophthalmic use only and requires proper handling to ensure sterility. Authorized under FDA_PMA (PMA Number: P840055), it adheres to regulatory standards for Class II devices under 21 CFR 886.5916. Storage and handling must comply with manufacturer guidelines to preserve integrity, and its design does not include MRI compatibility considerations.

Other devices from The Lifestyle Company, Inc.

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.

  • Are the SGP LENS™ lenses designed for continuous wear, or are they meant for daily use only?

    The SGP LENS™ are explicitly designed as daily-wear contact lenses, intended for short-term, single-use applications. They are not meant for continuous wear and must be replaced daily to maintain ocular health and comfort, as specified in their classification under *Lens, Contact (Other Material) – Daily*.

  • How should the SGP LENS™ be stored to ensure they remain sterile and intact?

    The SGP LENS™ must be stored and handled according to manufacturer guidelines to preserve sterility and integrity. Since they are single-use and non-reusable, proper packaging and environmental conditions (e.g., dry, protected from contamination) are critical. The device’s regulatory classification and handling instructions emphasize maintaining sterility for ophthalmic use.

  • What regulatory pathway was followed for the approval of the SGP LENS™, and what class does it fall under?

    The SGP LENS™ was authorized under the FDA’s Premarket Approval (PMA) pathway, with PMA Number P840055. It is classified as a Class II medical device under 21 CFR 886.5916, adhering to strict regulatory standards for contact lenses. The approval reflects a thorough review by the FDA’s Ophthalmic Advisory Committee (OP).

  • Are there different sizes or models available for the SGP LENS™, or is it a one-size-fits-all design?

    The provided data does not specify individual sizes or models for the SGP LENS™, but it is classified under *Lens, Contact (Other Material) – Daily*, which typically includes various prescriptions (e.g., spherical, toric) to correct refractive errors. For exact sizing or model variations, consult the manufacturer’s product catalog or technical documentation.