Cleared Traditional

K863361 - MODEL 8900 ND:YAG LASER

K863361 is an FDA 510(k) clearance for MODEL 8900 ND:YAG LASER, manufactured by Cooper Lasersonics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HHR cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K863361 · Cooper Lasersonics, Inc. · Obstetrics & Gynecology device
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Nov 1986
Decision
83d
Days
Class 2
Risk

K863361 is an FDA 510(k) clearance for the MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on November 24, 1986 after a review of 83 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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K863361

510(k) Number K863361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1986
Decision Date November 24, 1986
Days to Decision 83 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
77d faster than avg
Panel avg: 160d · This submission: 83d
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 16
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K863361.
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
K872253 · Surgical Laser Technologies, Inc. · Oct 1987
MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.
K871220 · Cooper Lasersonics, Inc. · Jul 1987
OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN
K863221 · Laserscope · Mar 1987
SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
K862861 · Directed Energy, Inc. · Oct 1986
CABOT LASER LAPAROSCOPY ACCESSORY SET
K862228 · Cabot Medical Corp. · Aug 1986
ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION
K862456 · Cooper Lasersonics, Inc. · Aug 1986