Cleared Traditional

K990233 - ST-302 INFRAREX

K990233 is an FDA 510(k) clearance for ST-302 INFRAREX, manufactured by Skylark Device Co., Ltd.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K990233 · Skylark Device Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
275d
Days
Class 2
Risk

K990233 is an FDA 510(k) clearance for the ST-302 INFRAREX. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on October 27, 1999 after a review of 275 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K990233

510(k) Number K990233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1999
Decision Date October 27, 1999
Days to Decision 275 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 115d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 30
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K990233.
PALOMAR LIGHTCUBE
K024179 · Palomar Medical Products, Inc. · Jun 2003
SURGICAL PATIENT WARMER, MODEL PW820 JHU
K022609 · Fisher &Paykel Healthcare , Ltd. · Mar 2003
OLYMPIC WARM-UP
K001056 · Olympic Medical Corp. · Sep 2000
PATIENT WARMER- MODEL PW810
K982636 · Fisher &Paykel Healthcare , Ltd. · Oct 1998
DERMATHERM 100
K980607 · New Star Lasers, Inc. · Apr 1998
OLYMPIC WARM-LAMP
K932881 · Olympic Medical Corp. · Jan 1994