Cleared Traditional

K861747 - KEELER FIBEROPTIC HEADLAMP
(FDA 510(k) Clearance)

K861747 · Keeler Instruments, Inc. · Ophthalmic

Aug 1986

Decision

107d

Days

Class 2

Risk

K861747 is an FDA 510(k) clearance for the KEELER FIBEROPTIC HEADLAMP. This device is classified as a Headlamp, Operating, Ac-powered (Class II — Special Controls, product code HPQ).

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on August 21, 1986, 107 days after receiving the submission on May 6, 1986.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4335.

Submission Details

510(k) Number	K861747 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 1986
Decision Date	August 21, 1986
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—