Cleared Traditional

K801197 - CO2 LASER

K801197 is an FDA 510(k) clearance for CO2 LASER, manufactured by Advanced Biomedical Instruments. The device is a Class 2 Obstetrics & Gynecology device with product code HHR cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K801197 · Advanced Biomedical Instruments · Obstetrics & Gynecology device
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Jun 1980
Decision
42d
Days
Class 2
Risk

K801197 is an FDA 510(k) clearance for the CO2 LASER. Classified as Laser, Surgical, Gynecologic (product code HHR), Class II - Special Controls.

Submitted by Advanced Biomedical Instruments (Walker, US). The FDA issued a Cleared decision on June 30, 1980 after a review of 42 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 Advanced Biomedical Instruments devices

FDA 510(k) Submission Details - K801197

510(k) Number K801197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1980
Decision Date June 30, 1980
Days to Decision 42 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
118d faster than avg
Panel avg: 160d · This submission: 42d
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.