Cleared Traditional

K844431 - YN CO2 LASER SYSTEM 30W

K844431 is the FDA 510(k) clearance for YN CO2 LASER SYSTEM 30W by Cryomedics, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HHR) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K844431 · Cryomedics, Inc. · Obstetrics & Gynecology device
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Feb 1985
Decision
101d
Days
Class 2
Risk

K844431 is an FDA 510(k) clearance for the YN CO2 LASER SYSTEM 30W. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Cryomedics, Inc. (Bridgeport, US). The FDA issued a Cleared decision on February 25, 1985 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cryomedics, Inc. devices

Submission Details

510(k) Number K844431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1984
Decision Date February 25, 1985
Days to Decision 101 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
59d faster than avg
Panel avg: 160d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K844431.
ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION
K862456 · Cooper Lasersonics, Inc. · Aug 1986
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
K861845 · Directed Energy, Inc. · Aug 1986
CO2 LASER LAPAROSCOPE SYSTEM
K854361 · Richard Wolf Medical Instruments Corp. · Feb 1986
LASER, CO2 SURGICAL
K782054 · Cavitron Corp. · Jan 1979