Cleared Traditional

K982063 - ALM PRISMALIX (PRX) SURGICAL LIGHT

K982063 is an FDA 510(k) clearance for ALM PRISMALIX (PRX) SURGICAL LIGHT, manufactured by Alm Surgical Equipment, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSY cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K982063 · Alm Surgical Equipment, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
102d
Days
Class 2
Risk

K982063 is an FDA 510(k) clearance for the ALM PRISMALIX (PRX) SURGICAL LIGHT. Classified as Light, Surgical, Ceiling Mounted (product code FSY), Class II - Special Controls.

Submitted by Alm Surgical Equipment, Inc. (Anaheim, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Alm Surgical Equipment, Inc. devices

FDA 510(k) Submission Details - K982063

510(k) Number K982063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1998
Decision Date September 22, 1998
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSY Device Classification - Class 2, Special Controls

Product Code FSY Light, Surgical, Ceiling Mounted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FSY Light, Surgical, Ceiling Mounted

All 59
Devices cleared under the same product code (FSY) and FDA review panel - the closest regulatory comparables to K982063.
CHROMOPHARE D 530 LDR SURGICAL LIGHT
K990656 · Berchtold Holding GmbH · Jul 1999
CHROMOPHARE D500, D530, D650
K991527 · Berchtold Holding GmbH · May 1999
DRAGER SOLA SERIES, MODELS 1000/700/500/300
K984611 · Drager Medizintechnik GmbH · Mar 1999
BRIGHTSTAR
K981081 · Hill-Rom, Inc. · Apr 1998
GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT
K974084 · Getinge/Castle, Inc. · Mar 1998
CHROMOPHARE D 500, CHROMOPHARE D 530
K974433 · Berchtold Holding GmbH · Feb 1998