Retinometer

FDA 510(k) K781507 · Coburn Optical Ind., Inc.

Substantially Equivalent

510(k) numberK781507

Submission

Device name
Retinometer
Applicant
Coburn Optical Ind., Inc.
Mchenry, IL, US
Received
September 1, 1978
Decision date
November 15, 1978
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

510(k)DeviceApplicantDecision
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
K813429Laser Photocoagulator Argon Med. LaserHPJ · Traditional American Laser Corp.01/22/1982SE

More from American Laser Corp.

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K862188Irrigation & Aspiration/Vitrectomy DeviceHQE · Traditional 08/21/1986SE
K853457Coburn I/A SystemHQE · Traditional 10/15/1985SE
K821737Disp. Microsurgical KnivesGES · Traditional 07/02/1982SE
K812441Di-CrownHQG · Traditional 10/06/1981SE
K803159Automated PerimetersHPT · Traditional 02/04/1981SE

Questions and answers

When was Retinometer cleared by the FDA?

Retinometer (K781507) received a 510(k) decision of Substantially Equivalent on November 15, 1978, 75 days after the submission was received.

What is the product code of K781507?

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