Gas Permeable Regimen

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Accessories, soft lens products

PMA Number

P820053 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

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See all devices from Advanced Medical Optics, Inc. →

• What is the primary purpose of the Gas Permeable Regimen and how does it differ from other contact lens accessories?

  The Gas Permeable Regimen is designed specifically as a reusable system to support the care and maintenance of gas-permeable contact lenses, not soft lenses. Unlike single-use or disposable lens accessories, this regimen is intended for repeated use in both clinical and home settings, requiring proper cleaning and disinfection per manufacturer instructions. It falls under FDA Class II and is authorized via Premarket Approval (PMA), distinguishing it from non-regulated accessories.

• Is the Gas Permeable Regimen sterile when unopened, and what cleaning procedures are required?

  The Gas Permeable Regimen is not sterile upon packaging and must be cleaned and disinfected according to the manufacturer’s guidelines before first use. Since it is a reusable system, proper maintenance is essential to ensure hygiene and functionality, as outlined in the accompanying instructions.

• How is this device regulated, and what does the PMA approval entail?

  The Gas Permeable Regimen is regulated under FDA Premarket Approval (PMA) with PMA number P820053 and supplement S003, adhering to 21 CFR 886.5928. This approval process ensures the device meets stringent safety and effectiveness standards for Class II medical devices, particularly as an accessory for ophthalmic use. The PMA route is used for devices where general controls alone are insufficient to provide reasonable assurance of safety and performance.

• Where can this device be used, and is it suitable for both clinical and home settings?

  The Gas Permeable Regimen is intended for use in both clinical and home settings, as explicitly stated in its description. It is designed to support the care of gas-permeable lenses, making it versatile for environments where lens maintenance is performed, whether by healthcare professionals or patients themselves. The reusable nature aligns with its dual-use designation.