Cleared Traditional

K863221 - OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR...

K863221 is the FDA 510(k) clearance for OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR... by Laserscope. It is a Class 2 Obstetrics & Gynecology device (product code HHR) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K863221 · Laserscope · Obstetrics & Gynecology device
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Mar 1987
Decision
193d
Days
Class 2
Risk

K863221 is an FDA 510(k) clearance for the OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Laserscope (Santa Clara, US). The FDA issued a Cleared decision on March 2, 1987 after a review of 193 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 Laserscope devices

Submission Details

510(k) Number K863221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1986
Decision Date March 02, 1987
Days to Decision 193 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
33d slower than avg
Panel avg: 160d · This submission: 193d
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 15
Devices cleared under the same product code (HHR) and FDA review panel - the closest regulatory comparables to K863221.
MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
K871579 · Sharplan Lasers, Inc. · Nov 1987
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
MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA
K863361 · Cooper Lasersonics, Inc. · Nov 1986
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