Downing Spectral Illuminator

FDA 510(k) K833446 · Vision Health Technology

Substantially Equivalent

510(k) numberK833446

Submission

Device name
Downing Spectral Illuminator
Applicant
Vision Health Technology
Walker, MI, US
Received
October 5, 1983
Decision date
March 12, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HLX – Photostimulator, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1630
Specialty
Ophthalmic

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More from Cadwell Laboratories, Inc.

510(k)DeviceDecision
K833539Dowing Ophthalmic Chair Ac-PoweredHME · Traditional 03/05/1984SE
K833538Dowing Ophthalmic Chair-Non/Ac PowerHMD · Traditional 03/05/1984SE

Questions and answers

When was Downing Spectral Illuminator cleared by the FDA?

Downing Spectral Illuminator (K833446) received a 510(k) decision of Substantially Equivalent on March 12, 1984, 159 days after the submission was received.

What is the product code of K833446?

The FDA product code is HLX – Photostimulator, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1630.