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FDA 510(k)

DMS-1000C DERMOABRADER

K-Number: K963204 · 1996-12-09

ApplicantAesthetic Lasers, Inc.
Decision Date1996-12-09
Product CodeGFE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DMS-1000C DERMOABRADER is the device name listed in this FDA 510(k) record. The listed applicant is Aesthetic Lasers, Inc.. It received FDA 510(k) clearance on 1996-12-09 under 510(k) number K963204. The device is classified under product code GFE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DMS-1000C DERMOABRADER?

DMS-1000C DERMOABRADER is a medical device that received FDA 510(k) clearance on 1996-12-09. The listed applicant is Aesthetic Lasers, Inc.. The 510(k) number is K963204.

When did DMS-1000C DERMOABRADER receive FDA 510(k) clearance?

DMS-1000C DERMOABRADER received FDA 510(k) clearance on 1996-12-09, under 510(k) number K963204.

Who is the listed applicant for DMS-1000C DERMOABRADER?

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

What is the FDA product code for DMS-1000C DERMOABRADER?

The FDA product code for DMS-1000C DERMOABRADER is GFE.

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: GFE)

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.

K905046DERMABRADERAaron Medical Industries

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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