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FDA 510(k)

Enlight 2100 (TPL-E2103-0)

K-Number: K250464 · 2025-09-10

ApplicantTimpel S.A.
Decision Date2025-09-10
Product CodeQEB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Enlight 2100 (TPL-E2103-0) is a medical device manufactured by Timpel S.A.. It received FDA 510(k) clearance on 2025-09-10 under approval number K250464. The device is classified under product code QEB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Enlight 2100 (TPL-E2103-0)?

Enlight 2100 (TPL-E2103-0) is a medical device that received FDA 510(k) clearance on 2025-09-10. It is manufactured by Timpel S.A.. The 510(k) number is K250464.

When was Enlight 2100 (TPL-E2103-0) approved by the FDA?

Enlight 2100 (TPL-E2103-0) received FDA 510(k) clearance on 2025-09-10, under approval number K250464.

What company makes Enlight 2100 (TPL-E2103-0)?

Enlight 2100 (TPL-E2103-0) is manufactured by Timpel S.A..

What is the FDA product code for Enlight 2100 (TPL-E2103-0)?

The FDA product code for Enlight 2100 (TPL-E2103-0) is QEB.

Other Devices by Timpel S.A.

K211135Enlight 2100 K222897Enlight 2100

Related Devices (Code: QEB)

DEN170072Enlight 1810Timpel, Inc. K211135Enlight 2100Timpel S.A. K222466AirTomBilab K222897Enlight 2100Timpel S.A. K243765LuMon(TM) SystemSentec AG

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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