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FDA 510(k)

LED PROLUX 770

K-Number: K061695 · 2006-09-14

ApplicantPeng Lim Enterprise Co., Ltd.
Decision Date2006-09-14
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LED PROLUX 770 is the device name listed in this FDA 510(k) record. The listed applicant is Peng Lim Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2006-09-14 under 510(k) number K061695. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED PROLUX 770?

LED PROLUX 770 is a medical device that received FDA 510(k) clearance on 2006-09-14. The listed applicant is Peng Lim Enterprise Co., Ltd.. The 510(k) number is K061695.

When did LED PROLUX 770 receive FDA 510(k) clearance?

LED PROLUX 770 received FDA 510(k) clearance on 2006-09-14, under 510(k) number K061695.

Who is the listed applicant for LED PROLUX 770?

The FDA 510(k) record lists Peng Lim Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED PROLUX 770?

The FDA product code for LED PROLUX 770 is EBZ.

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Other records listing Peng Lim Enterprise Co., Ltd. as applicant

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Related Devices (Code: EBZ)

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.

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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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