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)

FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER

K-Number: K131207 · 2013-10-09

ApplicantSurgical Instrument Engineering AG
Decision Date2013-10-09
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Engineering AG. It received FDA 510(k) clearance on 2013-10-09 under 510(k) number K131207. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER?

FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER is a medical device that received FDA 510(k) clearance on 2013-10-09. The listed applicant is Surgical Instrument Engineering AG. The 510(k) number is K131207.

When did FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER receive FDA 510(k) clearance?

FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER received FDA 510(k) clearance on 2013-10-09, under 510(k) number K131207.

Who is the listed applicant for FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER?

The FDA 510(k) record lists Surgical Instrument Engineering AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER?

The FDA product code for FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER is HQF.

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: HQF)

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.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

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.

↑