Who is the manufacturer of SOLO-CARE BRAND HARD SOLUTION?

Ciba Vision Corporation submitted the Traditional clearance for SOLO-CARE BRAND HARD SOLUTION (K000607).

What is the FDA product code for SOLO-CARE BRAND HARD SOLUTION?

MRC. It is classified under 21 CFR 886.5918 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for SOLO-CARE BRAND HARD SOLUTION?

510(k) clearance (submission type: Traditional).

SOLO-CARE BRAND HARD SOLUTION

K000607 · Ciba Vision Corporation · MRC · May 15, 2000 · Ophthalmic

Device Facts

Record ID	K000607
Device Name	SOLO-CARE BRAND HARD SOLUTION
Applicant	Ciba Vision Corporation
Product Code	MRC · Ophthalmic
Decision Date	May 15, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.5918
Device Class	Class 2

Regulatory Classification

Identification

A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”