Cleared Traditional

K854361 - CO2 LASER LAPAROSCOPE SYSTEM

K854361 is an FDA 510(k) clearance for CO2 LASER LAPAROSCOPE SYSTEM, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HHR cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K854361 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
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Feb 1986
Decision
98d
Days
Class 2
Risk

K854361 is an FDA 510(k) clearance for the CO2 LASER LAPAROSCOPE SYSTEM. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Rosemont, US). The FDA issued a Cleared decision on February 4, 1986 after a review of 98 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K854361

510(k) Number K854361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date February 04, 1986
Days to Decision 98 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 160d · This submission: 98d
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 23
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K854361.
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
MODEL J25-25 WATT CO2 LASER
K851425 · Britt Corp., Inc. · Nov 1985
LASER, CO2 SURGICAL
K782054 · Cavitron Corp. · Jan 1979