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FDA 510(k)

SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE

K-Number: K121030 · 2012-07-06

ApplicantSacks Holdings, Inc.
Decision Date2012-07-06
Product CodeLRX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE is the device name listed in this FDA 510(k) record. The listed applicant is Sacks Holdings, Inc.. It received FDA 510(k) clearance on 2012-07-06 under 510(k) number K121030. 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 SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE?

SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE is a medical device that received FDA 510(k) clearance on 2012-07-06. The listed applicant is Sacks Holdings, Inc.. The 510(k) number is K121030.

When did SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE receive FDA 510(k) clearance?

SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE received FDA 510(k) clearance on 2012-07-06, under 510(k) number K121030.

Who is the listed applicant for SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE?

The FDA 510(k) record lists Sacks Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE?

The FDA product code for SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE is LRX.

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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.K231123Phoenix 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 Innovative Healthcare Manufacturers Pvt. , Ltd.K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc.K172925Contact Lens Case, Model: A-1, B-1P L Overseas Limited

Official Source

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

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