Blue Eye
K-Number: K241591 · 2024-07-03
ApplicantThe Standard Co., Ltd.
Decision Date2024-07-03
Product CodePLL
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Blue Eye is a medical device manufactured by The Standard Co., Ltd.. It received FDA 510(k) clearance on 2024-07-03 under approval number K241591. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Blue Eye?
Blue Eye is a medical device that received FDA 510(k) clearance on 2024-07-03. It is manufactured by The Standard Co., Ltd.. The 510(k) number is K241591.
When was Blue Eye approved by the FDA?
Blue Eye received FDA 510(k) clearance on 2024-07-03, under approval number K241591.
What company makes Blue Eye?
Blue Eye is manufactured by The Standard Co., Ltd..
What is the FDA product code for Blue Eye?
The FDA product code for Blue Eye is PLL.
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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.