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FDA 510(k)

DOCTOR SMILE A-810 AND B-980 LASERS

K-Number: K091562 · 2009-09-08

ApplicantLambda Scientific Spa
Decision Date2009-09-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DOCTOR SMILE A-810 AND B-980 LASERS is the device name listed in this FDA 510(k) record. The listed applicant is Lambda Scientific Spa. It received FDA 510(k) clearance on 2009-09-08 under 510(k) number K091562. 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 SMILE A-810 AND B-980 LASERS?

DOCTOR SMILE A-810 AND B-980 LASERS is a medical device that received FDA 510(k) clearance on 2009-09-08. The listed applicant is Lambda Scientific Spa. The 510(k) number is K091562.

When did DOCTOR SMILE A-810 AND B-980 LASERS receive FDA 510(k) clearance?

DOCTOR SMILE A-810 AND B-980 LASERS received FDA 510(k) clearance on 2009-09-08, under 510(k) number K091562.

Who is the listed applicant for DOCTOR SMILE A-810 AND B-980 LASERS?

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

What is the FDA product code for DOCTOR SMILE A-810 AND B-980 LASERS?

The FDA product code for DOCTOR SMILE A-810 AND B-980 LASERS 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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