Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
FDA 510(k) K231123 · Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
510(k) numberK231123
Submission
- Device name
- Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)
- Applicant
- Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
Navi Mumbai, IN - Received
- April 20, 2023
- Decision date
- August 30, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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 |
| 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 |
| K160005 | Contact Lens Case (multiple brand name)LRX · Traditional | Danyang Chanxin Glasses Cases Factory | 06/07/2016SE |
More from Danyang Chanxin Glasses Cases Factory
| 510(k) | Device | Decision |
|---|---|---|
| K201032 | Phoenix Digital ThermometerFLL · Traditional | 10/29/2021SE |
Questions and answers
When was Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) cleared by the FDA?
Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) (K231123) received a 510(k) decision of Substantially Equivalent on August 30, 2023, 132 days after the submission was received.
What is the product code of K231123?
The FDA product code is LRX – Case, Contact Lens, a Class II (moderate risk) device regulated under 21 CFR 886.5928.