Fyodorov Radial Keratotomy Marker Set

FDA 510(k) K860329 · Med-Tech Develoment Corp.

Substantially Equivalent

510(k) numberK860329

Submission

Device name
Fyodorov Radial Keratotomy Marker Set
Applicant
Med-Tech Develoment Corp.
Clearwater, FL, US
Received
January 29, 1986
Decision date
February 12, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HHR – Laser, Surgical, Gynecologic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4550
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HHR

510(k)DeviceApplicantDecision
K881507Endocoagulator Model 20 Laser & AccessoriesHHR · Traditional Hgm Medical Laser Systems, Inc.04/27/1989SE
K871875Model 5050 Surgilaser for Ob-Gyn UseHHR · Traditional Lasermatic, Inc.08/22/1988SE
K875314GL-35 Colposcopic Laser SystemHHR · Traditional Laser Engineering, Inc.08/05/1988SE
K874615Laser Cannister FilterHHR · Traditional Medical Marketing, Inc.06/23/1988SE
K880591Laseguide 600A, 600B, 400A, 400B for Ob-Gyn UseHHR · Traditional Laser Peripherals, LLC06/01/1988SE
K880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LaseHHR · Traditional Copper Lasersonics, Inc.05/31/1988SE
K880991Laser Optical Catheter SystemHHR · Traditional Medline Industries, Inc.05/25/1988SE
K880173Model 4900 Nd:Yag Laser for Endometrial AblationHHR · Traditional Cooper Lasersonics, Inc.03/24/1988SE
K874837KTP/532 Laser for Ob-Gyn UseHHR · Traditional Laserscope03/14/1988SE
K875078Heracure LS 500HHR · Traditional W.C. Heraeus GmbH02/22/1988SE

More from W.C. Heraeus GmbH

510(k)DeviceDecision
K860852Sapphire Blade Surgical KnifeHNN · Traditional 03/28/1986SE
K860332Diamond Blade Micrometer KnifeHNN · Traditional 02/13/1986SE
K860331Disposable Surgical KnifeHNN · Traditional 02/12/1986SE
K860330Maklakov Style TonometerHKY · Traditional 02/12/1986SE

Questions and answers

When was Fyodorov Radial Keratotomy Marker Set cleared by the FDA?

Fyodorov Radial Keratotomy Marker Set (K860329) received a 510(k) decision of Substantially Equivalent on February 12, 1986, 14 days after the submission was received.

What is the product code of K860329?

The FDA product code is HHR – Laser, Surgical, Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4550.