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)

STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM

K-Number: K123177 · 2013-07-03

ApplicantLaserstim, Inc.
Decision Date2013-07-03
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laserstim, Inc.. It received FDA 510(k) clearance on 2013-07-03 under 510(k) number K123177. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM?

STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-07-03. The listed applicant is Laserstim, Inc.. The 510(k) number is K123177.

When did STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM receive FDA 510(k) clearance?

STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM received FDA 510(k) clearance on 2013-07-03, under 510(k) number K123177.

Who is the listed applicant for STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM?

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

What is the FDA product code for STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM?

The FDA product code for STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM is ILY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: ILY)

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.

K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd.K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company , Ltd.K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc.K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.

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.

↑