Opti-Free Contact Lens Case
FDA 510(k) K931620 · Alcon Laboratories
510(k) numberK931620
Submission
- Device name
- Opti-Free Contact Lens Case
- Applicant
- Alcon Laboratories
Fort Worth, TX, US - Received
- April 2, 1993
- Decision date
- June 28, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K252175 | LANDR Contact LENS CaseLRX · Traditional | Fourth Axis, LLC | 02/10/2026SE |
| K250495 | Mini VP1 (PL67_F); Mini VP1 (PL61_F)LRX · Traditional | Avizor S.A. | 08/01/2025SE |
| K240095 | CAREUS 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 |
| K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case -…LRX · Traditional | Phoenix Innovative Healthcare Manufacturers Pvt.… | 08/30/2023SE |
| K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscLRX · Special | Alcon Laboratories, Inc. | 12/04/2017SE |
| K172925 | Contact Lens Case, Model: A-1, B-1LRX · Traditional | P L Overseas Limited | 11/30/2017SE |
| K173365 | Bausch + Lomb Boston Scleral Lens CaseLRX · Traditional | Bausch & Lomb, Incorporated | 11/17/2017SE |
| K171539 | Contact Lens CaseLRX · Traditional | E-Link Plastic & Metal Industrial Co.,Ltd | 07/14/2017SE |
| K171163 | Contact Lens Case Round GlassesLRX · Traditional | Fiftytwoways, Ltd. | 06/27/2017SE |
| K162869 | Contact Lens CaseLRX · Traditional | Ningbo Yinzhou Zonghai Artware Co., Ltd. | 12/09/2016SE |
More from Ningbo Yinzhou Zonghai Artware Co., Ltd.
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| K243896 | LenSx Laser System (8065998162)OOE · Traditional | 04/28/2025SE |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism…LPL · Special | 01/13/2025SE |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…MPA · Traditional | 12/04/2024SE |
| K233876 | Unity VCS (8065000296); Unity CS (8065000297)HQC · Traditional | 06/21/2024SE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057)HQC · Special | 01/10/2024SE |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…LPL · Special | 12/29/2023SE |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…LPL · Traditional | 11/16/2023SE |
| K230785 | Precision1, Precision1 for AstigmatismLPL · Special | 04/20/2023SE |
Questions and answers
When was Opti-Free Contact Lens Case cleared by the FDA?
Opti-Free Contact Lens Case (K931620) received a 510(k) decision of Substantially Equivalent on June 28, 1993, 87 days after the submission was received.
What is the product code of K931620?
The FDA product code is LRX – Case, Contact Lens, a Class II (moderate risk) device regulated under 21 CFR 886.5928.