FDA 510(k)

SUPERLITE PENLIGHT

K-Number: K861028 · 1986-04-04

Decision Date1986-04-04

Product Code

DecisionSubstantially Equivalent

Device Summary

SUPERLITE PENLIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Keta Corp.. It received FDA 510(k) clearance on 1986-04-04 under 510(k) number K861028. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERLITE PENLIGHT?

SUPERLITE PENLIGHT is a medical device that received FDA 510(k) clearance on 1986-04-04. The listed applicant is Keta Corp.. The 510(k) number is K861028.

When did SUPERLITE PENLIGHT receive FDA 510(k) clearance?

SUPERLITE PENLIGHT received FDA 510(k) clearance on 1986-04-04, under 510(k) number K861028.

Who is the listed applicant for SUPERLITE PENLIGHT?

The FDA 510(k) record lists Keta Corp. 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Keta Corp. as applicant

K861027KETA HAND-HELD TONOMETER K844570QUANTUM 412

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.