Improved Soaclens
PMA P830071
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP830071 | Date30 Dec 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic name
- Accessories, soft lens products
- FDA applicant
- Alcon Laboratories
- 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
- S002 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The Improved Soaclens is a soft contact lens accessory designed for ophthalmic use. Classified under the nomenclature for soft lens products, it is intended for cleaning, storing, or disinfecting soft contact lenses in a controlled environment.
Supplied as a reusable device, the Improved Soaclens is regulated under FDA Premarket Approval (PMA) with PMA number P830071 and supplement S002. It adheres to regulatory requirements outlined in 21 CFR 886.5928 and is manufactured by Alcon Laboratories, Inc., with a primary advisory committee classification in ophthalmics. Multiple registration numbers and FEI numbers identify its variants, ensuring traceability and compliance with regulatory standards.
Other devices from Alcon Laboratories, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the Improved Soaclens designed to do for soft contact lenses, and how does it differ from other cleaning or storage accessories?
The Improved Soaclens is specifically designed for cleaning, storing, or disinfecting soft contact lenses in a controlled environment. Unlike some single-use or disposable accessories, this device is reusable, meaning it is intended for repeated use over time. Its regulatory classification under 21 CFR 886.5928 and FDA Premarket Approval (PMA) indicate it meets strict standards for ophthalmic accessories, ensuring safety and efficacy for long-term lens care.
Is the Improved Soaclens sterile when first received, and if not, how should it be prepared for first-time use?
The device data does not explicitly state whether the Improved Soaclens is sterile upon receipt, but since it is a reusable accessory regulated under FDA PMA, it is likely intended for cleaning and disinfection rather than being pre-sterilized. For first-time use, it should be thoroughly cleaned and disinfected following the manufacturer’s instructions (available from Alcon Laboratories) to ensure proper hygiene before use with contact lenses.
How do I identify the correct variant of the Improved Soaclens for my practice, given the multiple registration and FEI numbers listed?
The Improved Soaclens comes in multiple variants, each identified by unique registration numbers (e.g., 3006140792, 3012236936) and FEI numbers (e.g., 3006140792, 3012603529). These identifiers are used for regulatory traceability and compliance but do not indicate functional differences. To ensure you select the correct variant, confirm with Alcon Laboratories or your supplier which specific registration number aligns with your intended use or purchase order.
What storage requirements should I follow for the Improved Soaclens to maintain its performance and hygiene?
While the data does not specify exact storage conditions, reusable medical devices like the Improved Soaclens should generally be stored in a clean, dry environment away from direct sunlight or extreme temperatures. After each use, it should be cleaned and disinfected as per manufacturer guidelines to prevent contamination. Proper storage ensures longevity and maintains the device’s effectiveness for cleaning and disinfecting soft contact lenses.