RGP Contact Lens Solution: What It Is and How FDA Defines It

General product information, not medical advice. Follow the instructions of your eye care professional and the product label.

What is RGP contact lens solution? (short answer)

RGP contact lens solution means the care products made for rigid gas permeable lenses. In US regulation they are a device category of their own, 21 CFR 886.5918, covering cleaning, conditioning, rinsing, lubricating/rewetting and storing, and including tablets. They are Class II (special controls).

Definition and scope

The regulation defines these products as a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens, and states that this includes all solutions and tablets used together with such lenses. The classification is Class II (Special Controls), and the regulation points to FDA’s premarket notification (510(k)) guidance document for contact lens care products.

The word “solution” is therefore broader than one bottle. Under the regulation, a cleaner, a conditioning or storage solution, a rewetting product and a tablet used with RGP lenses all fall under the same device heading. For how RGP lens materials differ from soft lenses, see contact lens materials.

How do manufacturers describe RGP lens care products?

Product design varies by lens maker, so the label of the product is the authority for any specific product. One manufacturer’s published two-step system shows the pattern. Menicon describes CLEANER R as a solution for cleaning RGP lenses, followed by a rinse with CONDITIONER R, and describes CONDITIONER R as a specific solution for the hydration, disinfection and storage of RGP lenses. Both products list a discard date after opening on the product page. This is one manufacturer’s example, not a rule for every product.

FDA’s general guidance on contact lens products says sterile saline solutions are for rinsing only and are not for cleaning and disinfecting lenses; see contact lens saline solution. FDA’s page addresses contact lenses generally and does not single out RGP lenses.

Types of RGP care product

The table maps each function named in 21 CFR 886.5918 to what the sources state about it.

Function in 21 CFR 886.5918	What the sources state
Cleaning	Covered by the regulation. Menicon markets CLEANER R as a solution for cleaning RGP lenses.
Conditioning	Covered by the regulation. Menicon describes its conditioner as providing hydration and disinfection.
Rinsing	Covered by the regulation. FDA: sterile saline is for rinsing only, not for cleaning or disinfecting.
Lubricating/rewetting	Covered by the regulation as a named function.
Storing	Covered by the regulation. Menicon describes its conditioner as a storage solution for RGP lenses.

Where does it matter for labs, clinics and supply records?

For staff who catalogue eye-care consumables, the sourced label and record checkpoints are short.

• The label states that the product is for rigid gas permeable lenses; a regulatory heading exists specifically for RGP care products.
• The product’s stated function (cleaning, conditioning, rinsing, rewetting or storing) matches how it is catalogued.
• The discard date after opening, where the manufacturer prints one, is recorded with the item.
• Saline is catalogued separately from cleaners and storage solutions, since FDA limits saline to rinsing.
• Lens cases are catalogued as their own item.

For a wider view of what an optometry practice stocks, see the optometry clinic supply checklist, and for cases see contact lens case replacement.

Common misunderstandings

• “Saline is a complete lens solution.” FDA says sterile saline is for rinsing only, not for cleaning and disinfecting.
• “RGP care is the same as soft-lens care.” The regulation gives RGP care products their own heading, 21 CFR 886.5918, and lists conditioning among its functions.
• “One product does every function.” The regulation lists several functions; which ones a given product covers is stated on its own label.

FAQ

What does 21 CFR 886.5918 cover?

It covers devices intended for the cleaning, conditioning, rinsing, lubricating/rewetting or storing of a rigid gas permeable contact lens, including all solutions and tablets used together with RGP lenses.

What FDA class are RGP lens care products?

Class II (Special Controls), with FDA’s 510(k) guidance document for contact lens care products named in the regulation.

Does saline count as RGP lens solution?

FDA says sterile saline solutions are for rinsing only and are not for cleaning and disinfecting lenses, so saline is not a complete care product.

Is RGP solution the same as soft contact lens solution?

RGP care products have their own regulatory heading; the label of a product states which lens type it is intended for. For lens types, see contact lens materials.

Sources

All sources checked 2026-10-31.

• 21 CFR 886.5918, Rigid gas permeable contact lens care products, eCFR: https://www.ecfr.gov/current/title-21/section-886.5918
• FDA, Contact Lens Solutions and Products, page content current as of 01/16/2018: https://www.fda.gov/medical-devices/contact-lenses/contact-lens-solutions-and-products
• Menicon, CONDITIONER R, manufacturer product page: https://www.menicon.com/consumer/products/lens-care-products/conditioner-r
• Menicon, CLEANER R, manufacturer product page: https://www.menicon.com/consumer/products/lens-care-products/cleaner-r