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FDA 510(k)

S2 Pigment Removal System

K-Number: K202848 · 2021-12-14

ApplicantLightsense Technologies, Ltd.
Decision Date2021-12-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

S2 Pigment Removal System is the device name listed in this FDA 510(k) record. The listed applicant is Lightsense Technologies, Ltd.. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K202848. 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 S2 Pigment Removal System?

S2 Pigment Removal System is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Lightsense Technologies, Ltd.. The 510(k) number is K202848.

When did S2 Pigment Removal System receive FDA 510(k) clearance?

S2 Pigment Removal System received FDA 510(k) clearance on 2021-12-14, under 510(k) number K202848.

Who is the listed applicant for S2 Pigment Removal System?

The FDA 510(k) record lists Lightsense Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S2 Pigment Removal System?

The FDA product code for S2 Pigment Removal System 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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