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Crystalens Saline Spray

by Stericon, Inc.

PMA P850065

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P850065↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP850065 Date27 Jun 1986ApprovedStatusActive

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  • Withdrawn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 PMA Active

Specification

PMA

Generic Name
Accessories, soft lens products
PMA Number
FDA Product Code
LPN
Device Class
Class II
Regulation
21 CFR Part 886.5928
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S001

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 Crystalens Saline Spray is a sterile ophthalmic accessory designed for soft lens products. Classified as an accessory for intraocular lenses, it is intended to facilitate cleaning, irrigation, or lubrication of the lens during surgical procedures or post-operative care.

Supplied as a single-use device, the Crystalens Saline Spray is intended for use in sterile ophthalmic settings. It is regulated under FDA PMA (P850065) and falls under the classification of Class II medical devices (LPN). The device is packaged in a sterile, non-pyrogenic formulation for safe application in surgical environments.

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 Crystalens Saline Spray primarily used for in surgical settings?

    The Crystalens Saline Spray is designed to assist with cleaning, irrigation, or lubrication of soft intraocular lenses during cataract surgery or other ophthalmic procedures. Its sterile, non-pyrogenic formulation ensures safe application in sterile environments, helping to maintain lens clarity and reduce friction during handling.

  • Is the Crystalens Saline Spray intended for reuse, or is it meant to be used only once?

    The Crystalens Saline Spray is explicitly labeled as a single-use device. This ensures sterility and safety in sterile ophthalmic settings, preventing cross-contamination between patients or procedures.

  • How is the Crystalens Saline Spray packaged, and what does this mean for storage?

    The device is packaged in a sterile, non-pyrogenic formulation, which means it is pre-sterilized and sealed for single-use. Storage should follow standard sterile medical device protocols—keep in a clean, dry place away from direct sunlight, and avoid exposure to extreme temperatures to preserve sterility and integrity until use.

  • What regulatory pathway was followed for the approval of the Crystalens Saline Spray?

    The Crystalens Saline Spray was approved through the FDA’s Premarket Approval (PMA) process, indicated by the PMA number P850065. This pathway is typically used for higher-risk devices, and the product is classified as a Class II medical device under the product code LPN, confirming its regulatory oversight.