Laser Photocoagulator Argon Med. Laser

FDA 510(k) K813429 · American Laser Corp.

Substantially Equivalent

510(k) numberK813429

Submission

Device name
Laser Photocoagulator Argon Med. Laser
Applicant
American Laser Corp.
Mchenry, IL, US
Received
December 8, 1981
Decision date
January 22, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HPJ – Instrument, Visual Field, Laser
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1360
Specialty
Ophthalmic

Other 510(k)s with product code HPJ

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K864012Iras PerimeterHPJ · Traditional Randwal Instrument Co., Inc.12/12/1986SE
K853556Laser IrasHPJ · Traditional Randwal Instrument Co., Inc.11/01/1985SE
K822415The Ocuplot DHPJ · Traditional Coherent Medical Division09/07/1982SE
K781507RetinometerHPJ · Traditional Coburn Optical Ind., Inc.11/15/1978SE

More from Coburn Optical Ind., Inc.

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K990725Nuvolase 532 Laser SystemGEX · Special 03/22/1999SE
K827819Laser Photocoagulator · Traditional 01/07/1983SE

Questions and answers

When was Laser Photocoagulator Argon Med. Laser cleared by the FDA?

Laser Photocoagulator Argon Med. Laser (K813429) received a 510(k) decision of Substantially Equivalent on January 22, 1982, 45 days after the submission was received.

What is the product code of K813429?

The FDA product code is HPJ – Instrument, Visual Field, Laser, a Class II (moderate risk) device regulated under 21 CFR 886.1360.