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FDA 510(k)

DOCTOR SURGERY DIODE LASERS FAMILY

K-Number: K102036 · 2010-09-28

ApplicantLambda S.P.A.
Decision Date2010-09-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DOCTOR SURGERY DIODE LASERS FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Lambda S.P.A.. It received FDA 510(k) clearance on 2010-09-28 under 510(k) number K102036. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOCTOR SURGERY DIODE LASERS FAMILY?

DOCTOR SURGERY DIODE LASERS FAMILY is a medical device that received FDA 510(k) clearance on 2010-09-28. The listed applicant is Lambda S.P.A.. The 510(k) number is K102036.

When did DOCTOR SURGERY DIODE LASERS FAMILY receive FDA 510(k) clearance?

DOCTOR SURGERY DIODE LASERS FAMILY received FDA 510(k) clearance on 2010-09-28, under 510(k) number K102036.

Who is the listed applicant for DOCTOR SURGERY DIODE LASERS FAMILY?

The FDA 510(k) record lists Lambda S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOCTOR SURGERY DIODE LASERS FAMILY?

The FDA product code for DOCTOR SURGERY DIODE LASERS FAMILY is GEX. This falls under the Gastroenterology category.

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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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