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)

ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY

K-Number: K853876 · 1986-02-21

ApplicantEndo Lase, Inc.
Decision Date1986-02-21
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Endo Lase, Inc.. It received FDA 510(k) clearance on 1986-02-21 under 510(k) number K853876. The device is classified under product code HHR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY?

ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY is a medical device that received FDA 510(k) clearance on 1986-02-21. The listed applicant is Endo Lase, Inc.. The 510(k) number is K853876.

When did ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY receive FDA 510(k) clearance?

ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY received FDA 510(k) clearance on 1986-02-21, under 510(k) number K853876.

Who is the listed applicant for ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY?

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

What is the FDA product code for ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY?

The FDA product code for ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY is HHR.

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

Other records listing Endo Lase, Inc. 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.

K853900ENDO-LASE CD40 FOR NEUROSURGERYK853878ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERYK855093MEDILAS 2 ND:YAG LASER SURGERY SYSTEMK853903ENDO-LASE CD40 CO2 FOR GYNECOLOGYK853901ENDO-LASE CD 40 FOR DERMATOLOGYK853877ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY

View all 24 devices →

Related Devices (Code: HHR)

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.

K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.K871875MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.K875314GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.K874615LASER CANNISTER FILTERMedical Marketing, Inc.K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLCK880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, 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.

↑