Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
FDA 510(k) K173538 · Alcon Laboratories, Inc.
510(k) numberK173538
Submission
- Device name
- Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
- Applicant
- Alcon Laboratories, Inc.
Fort Worth, TX, US - Received
- November 15, 2017
- Decision date
- December 4, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRX – Case, Contact Lens
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5928
- Specialty
- Ophthalmic
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| 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 |
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| 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 |
| K160005 | Contact Lens Case (multiple brand name)LRX · Traditional | Danyang Chanxin Glasses Cases Factory | 06/07/2016SE |
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Questions and answers
When was Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc cleared by the FDA?
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (K173538) received a 510(k) decision of Substantially Equivalent on December 4, 2017, 19 days after the submission was received.
What is the product code of K173538?
The FDA product code is LRX – Case, Contact Lens, a Class II (moderate risk) device regulated under 21 CFR 886.5928.