Cleared Traditional

K920248 - MODEL SLASE 210 HOLMIUM LASER SYSTEM

K920248 is an FDA 510(k) clearance for MODEL SLASE 210 HOLMIUM LASER SYSTEM, manufactured by Sunrise Technologies, Inc.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K920248 · Sunrise Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
182d
Days
Class 2
Risk

K920248 is an FDA 510(k) clearance for the MODEL SLASE 210 HOLMIUM LASER SYSTEM. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Sunrise Technologies, Inc. (Fremont, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 182 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunrise Technologies, Inc. devices

FDA 510(k) Submission Details - K920248

510(k) Number K920248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 21, 1992
Decision Date July 21, 1992
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 129d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 53
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K920248.
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THORA-KLEX CHEST DRAINAGE UNIT
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K901937 · Codman & Shurtleff, Inc. · Jul 1990