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)

PINPOINTE FOOTLASER

K-Number: K093547 · 2010-10-15

ApplicantPinpointe USA, Inc.
Decision Date2010-10-15
Product CodePDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PINPOINTE FOOTLASER is the device name listed in this FDA 510(k) record. The listed applicant is Pinpointe USA, Inc.. It received FDA 510(k) clearance on 2010-10-15 under 510(k) number K093547. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PINPOINTE FOOTLASER?

PINPOINTE FOOTLASER is a medical device that received FDA 510(k) clearance on 2010-10-15. The listed applicant is Pinpointe USA, Inc.. The 510(k) number is K093547.

When did PINPOINTE FOOTLASER receive FDA 510(k) clearance?

PINPOINTE FOOTLASER received FDA 510(k) clearance on 2010-10-15, under 510(k) number K093547.

Who is the listed applicant for PINPOINTE FOOTLASER?

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

What is the FDA product code for PINPOINTE FOOTLASER?

The FDA product code for PINPOINTE FOOTLASER is PDZ.

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: PDZ)

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.

K253960Medicell Mycosis Laser (MCML24004)Medicell Healthcare Co.,LTDK241116Onycho Laser VTerasysd&C, Inc.K211265TFX-LT2000 Therapy LightToefx, Inc.K221363AF LaserShenB Co., Ltd.K190034REMY Medical Therapy Laser SystemFootdocprenur, LLCK153164LunulaLaserErchonia Medical, 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.

↑