FDA 510(k)

S2 Pigment Removal System

K-Number: K202848 · 2021-12-14

Decision Date2021-12-14

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

S2 Pigment Removal System is a medical device manufactured by Lightsense Technologies, Ltd.. It received FDA 510(k) clearance on 2021-12-14 under approval 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. It is manufactured by Lightsense Technologies, Ltd.. The 510(k) number is K202848.

When was S2 Pigment Removal System approved by the FDA?

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

What company makes S2 Pigment Removal System?

S2 Pigment Removal System is manufactured by Lightsense Technologies, Ltd..

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.

Related Clinical Trials

NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07062094 Safety and Effectiveness of Orbera365™ Intragastric Balloon System RECRUITING NCT07465796 A First-in-Human Study of the CIPHER System During Brain Surgery for Newly Diagnosed Glioma RECRUITING NCT06689553 Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure TERMINATED NCT05729477 A Prospective Multicenter Study To Assess The Clinical Outcomes Of Current Phacoemulsification Approach To Cataract Extraction Versus The Micor System Device TERMINATED

Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

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.