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FDA 510(k)

Blue Eye (TS-905)

K-Number: K220434 · 2022-08-12

ApplicantThe Standard Co., Ltd.
Decision Date2022-08-12
Product CodePLL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Blue Eye (TS-905) is a medical device manufactured by The Standard Co., Ltd.. It received FDA 510(k) clearance on 2022-08-12 under approval number K220434. 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 (TS-905)?

Blue Eye (TS-905) is a medical device that received FDA 510(k) clearance on 2022-08-12. It is manufactured by The Standard Co., Ltd.. The 510(k) number is K220434.

When was Blue Eye (TS-905) approved by the FDA?

Blue Eye (TS-905) received FDA 510(k) clearance on 2022-08-12, under approval number K220434.

What company makes Blue Eye (TS-905)?

Blue Eye (TS-905) is manufactured by The Standard Co., Ltd..

What is the FDA product code for Blue Eye (TS-905)?

The FDA product code for Blue Eye (TS-905) is PLL.

Other Devices by The Standard Co., Ltd.

K241591Blue Eye

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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.

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