Contact Lens Remover Tool: Types and FDA Class

A contact lens remover tool is a small handheld accessory made for handling contact lenses. In US regulation the whole product class is called a contact lens inserter/remover, and it is a Class I medical device. This guide sets out what that class includes and which tool names appear in FDA records, so that clinic staff, buyers and students can tell tweezers, suction cups, soft lens handlers and scleral tools apart.

What is a contact lens remover tool?

Under 21 CFR 886.5420, “a contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.” Tweezers, suction cups, lens handlers and inserter tools are all variants of this one device type rather than separate regulated products. The regulation sits in Part 886 (Ophthalmic Devices), Subpart F (Therapeutic Devices). Checked 2026-10-30.

How FDA regulates contact lens inserter/removers

Class: Class I (general controls). The device is exempt from the premarket notification (510(k)) procedures in subpart E of part 807, subject to the limitations in 21 CFR 886.9 (21 CFR 886.5420(b)).
Product code: KYE, device name “Inserter/Remover Contact Lens”, regulation number 886.5420, medical specialty Ophthalmic (openFDA classification database, data last updated 2026-10-19).
Cleared under this code: openFDA lists 12 historical 510(k) clearances under KYE, dated from 1978 to 1987. They show how makers named these tools; they are not a list of products on sale today.

How the tools are built

The regulation defines the class by mechanism: surface adhesion or suction. In the FDA UDI database (AccessGUDID) the records under product code KYE include a soft lens handler described as “Contact lens remover/inserter for soft contact lenses. No suction”, a scleral tool described as having a suction bulb, and latex-free rubber suction cups, one listed as “autoclavable”.

Types and variants named in FDA records

Type	Name as it appears in the record	Source
Soft lens remover	“Soft Contact Lens Remover” (Magnivision, 1987)	510(k) K872567
Hard lens remover	“Hard Contact Lens Remover. Item #289” (Magnivision, 1987)	510(k) K872591
Tweezers	“Contact Lens Tweezers” (S. M. C. Medi-Tech, 1987)	510(k) K871130
Tweezers (soft lens)	“Marlin Soft Lens Tweezer” (Marlin Industries, 1985)	510(k) K850983
Soft lens handler	“Marlin Soft Lens Handler” (Marlin Industries, 1985)	510(k) K850984
Handler, no suction	“Contact lens remover/inserter for soft contact lenses. No suction”	AccessGUDID (openFDA UDI)
Inserter	“Soft Lens Inserter” (Soft-Sert, 1978)	510(k) K780931
Suction cup	Latex-free rubber and silicone suction cups listed under KYE	AccessGUDID (openFDA UDI)
Scleral lens tool	“ScleralEase: All-in-One Scleral Lens Application and Removal Tool”	AccessGUDID (openFDA UDI)

Contact lens tweezers

Tweezers appear in FDA records as a named tool type under the same product code, for example K871130 and K850983 above.

Contact lens suction cups

Suction cups are described in UDI records as rubber or silicone and latex-free, sold in packs of various counts. Because the regulation covers devices that work “by surface adhesion or suction”, they fall under the same Class I classification.

Contact lens inserter tools and scleral lens tools

Inserters are part of the same regulated class (“inserter/remover”). A scleral lens application and removal tool is listed in AccessGUDID under the same code.

Labeling

Which tool is intended for which lens type is stated in each product’s own labeling and the lens maker’s materials, and questions about a specific person’s lenses belong with an eye care professional. For lens context, see the CASRAI guides on contact lens materials and orthokeratology.

FAQ

Is a contact lens remover tool an FDA-regulated device?

Yes. FDA classifies the contact lens inserter/remover as a Class I device under 21 CFR 886.5420, exempt from 510(k) notification subject to the limitations in 21 CFR 886.9.

What is the difference between contact lens tweezers and a suction cup?

FDA records name both as tools in the same class. The regulation defines the class as handheld devices that insert or remove lenses by surface adhesion or suction; at least one record describes a soft lens handler as having no suction.

Is a contact lens inserter tool a different product from a remover?

No. FDA uses one device name, “Inserter/Remover Contact Lens”, for both functions under product code KYE.

Is a scleral lens tool in the same class?

AccessGUDID lists scleral lens application and removal tools under product code KYE, the same code as other inserter/removers.

Sources

All sources checked 2026-10-30.

21 CFR 886.5420, Contact lens inserter/remover: https://www.law.cornell.edu/cfr/text/21/886.5420
openFDA device classification, product code KYE: https://api.fda.gov/device/classification.json?search=product_code:KYE
openFDA 510(k) database, product code KYE: https://api.fda.gov/device/510k.json?search=product_code:KYE
openFDA UDI / AccessGUDID, product code KYE: https://api.fda.gov/device/udi.json?search=product_codes.code:KYE

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