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)

AMBULASE XAM-15 XANAR SURG. LASER

K-Number: K833325 · 1984-01-26

ApplicantXanar, Inc.
Decision Date1984-01-26
Product Code
DecisionSubstantially Equivalent

Device Summary

AMBULASE XAM-15 XANAR SURG. LASER is the device name listed in this FDA 510(k) record. The listed applicant is Xanar, Inc.. It received FDA 510(k) clearance on 1984-01-26 under 510(k) number K833325. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBULASE XAM-15 XANAR SURG. LASER?

AMBULASE XAM-15 XANAR SURG. LASER is a medical device that received FDA 510(k) clearance on 1984-01-26. The listed applicant is Xanar, Inc.. The 510(k) number is K833325.

When did AMBULASE XAM-15 XANAR SURG. LASER receive FDA 510(k) clearance?

AMBULASE XAM-15 XANAR SURG. LASER received FDA 510(k) clearance on 1984-01-26, under 510(k) number K833325.

Who is the listed applicant for AMBULASE XAM-15 XANAR SURG. LASER?

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

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 Xanar, 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.

K861688XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15K852436AMBULASEK860496MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARYK853620MODEL XA-50 - CO2 SURGICAL LASERK850804CO 2 SURGICAL LASER SYSTEM NA-30K850805CO 2 SURGICAL LASER SYSTEM MODEL NA-40

View all 12 devices →

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.

↑