Contact Lens Case for Soft Lenses

FDA 510(k) K840692 · Optimum Manufacturers, Inc.

Substantially Equivalent

510(k) numberK840692

Submission

Device name
Contact Lens Case for Soft Lenses
Applicant
Optimum Manufacturers, Inc.
Walker, MI, US
Received
February 16, 1984
Decision date
June 7, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LRX – Case, Contact Lens
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5928
Specialty
Ophthalmic

Other 510(k)s with product code LRX

510(k)DeviceApplicantDecision
K252175LANDR Contact LENS CaseLRX · Traditional Fourth Axis, LLC02/10/2026SE
K250495Mini VP1 (PL67_F); Mini VP1 (PL61_F)LRX · Traditional Avizor S.A.08/01/2025SE
K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)LRX · Traditional Shanghai Care US Medical Product Co., Ltd.10/09/2024SE
K231123Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case -…LRX · Traditional Phoenix Innovative Healthcare Manufacturers Pvt.…08/30/2023SE
K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscLRX · Special Alcon Laboratories, Inc.12/04/2017SE
K172925Contact Lens Case, Model: A-1, B-1LRX · Traditional P L Overseas Limited11/30/2017SE
K173365Bausch + Lomb Boston Scleral Lens CaseLRX · Traditional Bausch & Lomb, Incorporated11/17/2017SE
K171539Contact Lens CaseLRX · Traditional E-Link Plastic & Metal Industrial Co.,Ltd07/14/2017SE
K171163Contact Lens Case Round GlassesLRX · Traditional Fiftytwoways, Ltd.06/27/2017SE
K162869Contact Lens CaseLRX · Traditional Ningbo Yinzhou Zonghai Artware Co., Ltd.12/09/2016SE

More from Ningbo Yinzhou Zonghai Artware Co., Ltd.

510(k)DeviceDecision
K841163Contact Lens Inserter/RemoverHQD · Traditional 06/01/1984SE
K840691Contact Lens Case for Rigid Gas PermaLRX · Traditional 05/18/1984SE

Questions and answers

When was Contact Lens Case for Soft Lenses cleared by the FDA?

Contact Lens Case for Soft Lenses (K840692) received a 510(k) decision of Substantially Equivalent on June 7, 1984, 112 days after the submission was received.

What is the product code of K840692?

The FDA product code is LRX – Case, Contact Lens, a Class II (moderate risk) device regulated under 21 CFR 886.5928.