Opti-Free Express Multi-Purpose Solution

FDA 510(k) K981574 · Alcon

Substantially Equivalent

510(k) numberK981574

Submission

Device name
Opti-Free Express Multi-Purpose Solution
Applicant
Alcon
Fort Worth, TX, US
Received
May 4, 1998
Decision date
July 6, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LPN – Accessories, Soft Lens Products
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5928
Specialty
Ophthalmic

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Questions and answers

When was Opti-Free Express Multi-Purpose Solution cleared by the FDA?

Opti-Free Express Multi-Purpose Solution (K981574) received a 510(k) decision of Substantially Equivalent on July 6, 1998, 63 days after the submission was received.

What is the product code of K981574?

The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.