Infinity(R) Transilluminator Examination Light

FDA 510(k) K912252 · Fiberoptic Medical Products, Inc.

Substantially Equivalent

510(k) numberK912252

Submission

Device name
Infinity(R) Transilluminator Examination Light
Applicant
Fiberoptic Medical Products, Inc.
Philadelphia, PA, US
Received
May 21, 1991
Decision date
June 27, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FST – Light, Surgical, Fiberoptic
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

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Questions and answers

When was Infinity(R) Transilluminator Examination Light cleared by the FDA?

Infinity(R) Transilluminator Examination Light (K912252) received a 510(k) decision of Substantially Equivalent on June 27, 1991, 37 days after the submission was received.

What is the product code of K912252?

The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.