Cleared Traditional

K860329 - FYODOROV RADIAL KERATOTOMY MARKER SET

K860329 is an FDA 510(k) clearance for FYODOROV RADIAL KERATOTOMY MARKER SET, manufactured by Med-Tech Develoment Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HHR cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K860329 · Med-Tech Develoment Corp. · Obstetrics & Gynecology device
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Feb 1986
Decision
14d
Days
Class 2
Risk

K860329 is an FDA 510(k) clearance for the FYODOROV RADIAL KERATOTOMY MARKER SET. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Med-Tech Develoment Corp. (Clearwater, US). The FDA issued a Cleared decision on February 12, 1986 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4550 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Med-Tech Develoment Corp. devices

FDA 510(k) Submission Details - K860329

510(k) Number K860329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1986
Decision Date February 12, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 160d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHR Device Classification - Class 2, Special Controls

Product Code HHR Laser, Surgical, Gynecologic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHR Laser, Surgical, Gynecologic

All 24
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K860329.
ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY
K853876 · Endo Lase, Inc. · Feb 1986
ENDO-LASE CD40 CO2 FOR GYNECOLOGY
K853903 · Endo Lase, Inc. · Feb 1986
MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
K855093 · Endo Lase, Inc. · Feb 1986
CO2 LASER LAPAROSCOPE SYSTEM
K854361 · Richard Wolf Medical Instruments Corp. · Feb 1986
MODEL J25-25 WATT CO2 LASER
K851425 · Britt Corp., Inc. · Nov 1985
LASER, CO2 SURGICAL
K782054 · Cavitron Corp. · Jan 1979