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Hidrocor, Hidrocharme, and Natural Colors

by Solotica

510(k) K160472

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 NumberK160472 Date10 Aug 2016ClearedStatusActive

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  • Withdrawn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
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Hidrocor, Hidrocharme, and Natural Colors are soft contact lenses for daily wear. These lenses are designed to change eye color with natural-looking pigments and opaque colors. They are manufactured by Solotica and are available in various models and sizes.

These lenses are supplied as a Class II medical device with FDA 510(k) clearance. They are authorized for ophthalmic use and are not specified as single-use or reusable. The product code is LPL, and they are stored according to manufacturer instructions. The device is approved for distribution in the United States.

Questions

AI-generated answers, 23 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 are Hidrocor, Hidrocharme, and Natural Colors?

    These are soft contact lenses manufactured by Solotica designed for daily wear. They feature natural-looking pigments and opaque colors to change eye color.

  • Are these lenses single-use or reusable?

    The device data does not specify them as single-use or reusable. You must follow the manufacturer's storage and care instructions to determine their lifespan.

  • How are these lenses supplied?

    They are supplied as a Class II medical device with FDA 510(k) clearance. The product code is LPL, and they are approved for distribution in the United States.

  • What is the regulatory status of these lenses?

    The lenses have a decision of Substantially Equivalent and were reviewed by the Ophthalmic advisory committee. They are authorized for ophthalmic use.