Cleared Traditional

K851425 - MODEL J25-25 WATT CO2 LASER

K851425 is an FDA 510(k) clearance for MODEL J25-25 WATT CO2 LASER, manufactured by Britt Corp., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHR cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K851425 · Britt Corp., Inc. · Obstetrics & Gynecology device
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Nov 1985
Decision
216d
Days
Class 2
Risk

K851425 is an FDA 510(k) clearance for the MODEL J25-25 WATT CO2 LASER. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Britt Corp., Inc. (Los Angeles, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 216 days - an extended review 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: 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 Britt Corp., Inc. devices

FDA 510(k) Submission Details - K851425

510(k) Number K851425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1985
Decision Date November 12, 1985
Days to Decision 216 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
56d slower than avg
Panel avg: 160d · This submission: 216d
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 17
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K851425.
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