Identity
- Trade Name
- B&L THERMA-ZYME, FIZZICLEAN FDA PMA
- Generic Name
- Accessories, soft lens products FDA PMA
Identifiers
- PMA Number
- P850093 FDA PMA
- FDA Product Code
- LPN FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5928 FDA PMA
- Regulation Number
- 886.5928 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S003 (Normal 180 Day Track) FDA PMA
The Therma-Zyme Fizziclean is a soft lens cleaning solution designed for ophthalmic use. Classified as an accessory for soft contact lenses, it is intended to aid in the removal of deposits and proteins from lens surfaces during maintenance procedures.
This product is supplied as a liquid solution and is intended for single-use applications in a clinical or home setting. It is regulated under FDA Premarket Approval (PMA) with the designation P850093 and falls under product code LPN. Sterility and specific storage conditions are not detailed in the provided data, but compliance with ophthalmic cleaning protocols is implied for safe use.
Frequently asked questions
What is the primary purpose of the B&L Therma-Zyme Fizziclean in contact lens care, and how does it differ from standard cleaning solutions?
The B&L Therma-Zyme Fizziclean is specifically designed as a soft lens cleaning solution to aid in the removal of deposits and proteins from lens surfaces during maintenance. Unlike standard cleaning solutions, it is formulated as an accessory for soft contact lenses, emphasizing its role in enhancing cleaning efficacy through chemical action rather than mechanical scrubbing.
Is the B&L Therma-Zyme Fizziclean intended for use in both clinical and home settings, and how is it supplied?
Yes, the B&L Therma-Zyme Fizziclean is intended for single-use applications in both clinical and home settings. It is supplied as a liquid solution, which allows for easy dispensing and application directly to the lens surface during cleaning procedures.
What regulatory pathway was followed for the approval of the B&L Therma-Zyme Fizziclean, and what does this indicate about its oversight?
The B&L Therma-Zyme Fizziclean was approved through the FDA’s Premarket Approval (PMA) process, indicated by the PMA number P850093. This pathway suggests that the device underwent rigorous review by the FDA to ensure safety and effectiveness, particularly given its classification as a Class II medical device under product code LPN for ophthalmic accessories.
Are there multiple versions or sizes of the B&L Therma-Zyme Fizziclean, and how would one identify the correct variant for their needs?
The provided data lists multiple FEI numbers (e.g., 3006140792, 3012236936) and registration numbers, which likely correspond to different lot or variant identifiers for the product. While specific sizes or formulations aren’t detailed, these identifiers may help distinguish between batches or minor variations in the solution’s composition. For precise selection, consulting the manufacturer’s documentation or a healthcare provider is recommended.
What storage considerations should be taken into account for the B&L Therma-Zyme Fizziclean, and why are they important?
The data does not specify exact sterility or storage conditions, but as an ophthalmic accessory, it is implied that compliance with standard ophthalmic cleaning protocols is necessary for safe use. Typically, such solutions should be stored in a cool, dry place away from direct sunlight to preserve efficacy and prevent contamination. Proper storage ensures the solution remains effective for its intended purpose of cleaning soft contact lenses.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P850093 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P850093 23 fields · synced Sep 18, 2026