Cleared Traditional

K982546 - PHASER-2000

K982546 is an FDA 510(k) clearance for PHASER-2000, manufactured by Diomedics, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K982546 · Diomedics, Inc. · Physical Medicine device
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Sep 1998
Decision
63d
Days
Class 2
Risk

K982546 is an FDA 510(k) clearance for the PHASER-2000. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Diomedics, Inc. (Gainesville, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 63 days - a notably fast clearance 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: 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 Diomedics, Inc. devices

FDA 510(k) Submission Details - K982546

510(k) Number K982546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1998
Decision Date September 22, 1998
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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 38
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K982546.
ST-302 INFRAREX
K990233 · Skylark Device Co., Ltd. · Oct 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
PHOTONIC STIMULATOR
K974468 · Bales Scientific, Inc. · Jun 1998
DERMATHERM 100
K980607 · New Star Lasers, Inc. · Apr 1998
THERAPIK
K964397 · The Jenex Corporation · Nov 1997