Cleared Traditional

MODEL GLASE 210 HOLMIUM LASER SYSTEM (K904248) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904248 · Charles L. Rose and Co., Inc. · Obstetrics & Gynecology device
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Dec 1990
Decision
88d
Days
Class 2
Risk

K904248 is an FDA 510(k) clearance for the MODEL GLASE 210 HOLMIUM LASER SYSTEM. Classified as Source, Abortion Unit, Vacuum (product code HGF), Class II - Special Controls.

Submitted by Charles L. Rose and Co., Inc. (Mountain View, US). The FDA issued a Cleared decision on December 14, 1990 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5070 - 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 Charles L. Rose and Co., Inc. devices

Submission Details

510(k) Number K904248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1990
Decision Date December 14, 1990
Days to Decision 88 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
72d faster than avg
Panel avg: 160d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGF Source, Abortion Unit, Vacuum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5070
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.