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FDA 510(k)

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)

K-Number: K231123 · 2023-08-30

ApplicantPhoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
Decision Date2023-08-30
Product CodeLRX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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) is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K231123. The device is classified under product code LRX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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)?

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) is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.. The 510(k) number is K231123.

When did 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) receive FDA 510(k) clearance?

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) received FDA 510(k) clearance on 2023-08-30, under 510(k) number K231123.

Who is the listed applicant for 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)?

The FDA 510(k) record lists Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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)?

The FDA product code for 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) is LRX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07288658Comparing the Fit and Performance of Scleral Lenses With Oval and Circular Limbal ZonesCOMPLETED

Other records listing Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201032Phoenix Digital Thermometer

Related Devices (Code: LRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252175LANDR Contact LENS CaseFourth Axis, LLCK250495MINI VP1 (PL67_F); MINI VP1 (PL61_F)Avizor S.A.K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)Shanghai Care US Medical Product Co., Ltd.K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc.K172925Contact Lens Case, Model: A-1, B-1P L Overseas LimitedK173365Bausch + Lomb Boston Scleral Lens CaseBausch & Lomb, Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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