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
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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
159d slower than avg
Panel avg: 116d · 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 214
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K990233.
BIOPACK
K993685 · Bioscan, Inc. · Jul 2000
LIGHT PATCH
K993686 · Bioscan, Inc. · Jul 2000
QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B
K993123 · United Pacific Co., Ltd. · Dec 1999
SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36
K991503 · United Pacific Co., Ltd. · Jul 1999
PATIENT WARMER- MODEL PW810
K982636 · Fisher &Paykel Healthcare , Ltd. · Oct 1998
PHASER-2000
K982546 · Diomedics, Inc. · Sep 1998