Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Lotus III Multi-Pulsed Er: Yag Laser System

K-Number: K182045 · 2018-12-27

ApplicantLaseroptek Co., Ltd.
Decision Date2018-12-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lotus III Multi-Pulsed Er: Yag Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Laseroptek Co., Ltd.. It received FDA 510(k) clearance on 2018-12-27 under 510(k) number K182045. 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 Lotus III Multi-Pulsed Er: Yag Laser System?

Lotus III Multi-Pulsed Er: Yag Laser System is a medical device that received FDA 510(k) clearance on 2018-12-27. The listed applicant is Laseroptek Co., Ltd.. The 510(k) number is K182045.

When did Lotus III Multi-Pulsed Er: Yag Laser System receive FDA 510(k) clearance?

Lotus III Multi-Pulsed Er: Yag Laser System received FDA 510(k) clearance on 2018-12-27, under 510(k) number K182045.

Who is the listed applicant for Lotus III Multi-Pulsed Er: Yag Laser System?

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

What is the FDA product code for Lotus III Multi-Pulsed Er: Yag Laser System?

The FDA product code for Lotus III Multi-Pulsed Er: Yag Laser System is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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.

NCT07516106Prospective Multi-center Study Comparing Pulsed Tm:YAG Laser to Pulse Modulated Holmium Laser in the Treatment of Nephrolithiasis With FANS Access SheathsNOT_YET_RECRUITINGNCT04429607Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled TrialENROLLING_BY_INVITATIONNCT06721975Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)RECRUITINGNCT07599709LONG PULSED ND:YAG LASER (1064 NM) VERSUS INTENSE PULSED LIGHT IN TREATMENT OF TRAUMATIC AND POST-SURGICAL ERYTHEMATOUS SCARSCOMPLETEDNCT07739420A Randomized, Assessor-Blinded, Intraindividual Study on the Efficacy of Fractional Carbon Dioxide Laser Versus Long-Pulsed 1064 nm Nd:YAG Laser in the Treatment of Keratosis PilarisCOMPLETED

Other records listing Laseroptek Co., Ltd. as applicant

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.

K243780HELIOS 785 Pico (1754V2)K230373HELIOS 785 PicoK223588PALLAS PremiumK212663HELIOS IV 785K212573PicoLO PremiumK203491PicoLO Nd: YAG Picosecond Laser System

View all 11 devices →

Related Devices (Code: GEX)

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.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., 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.

↑