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http://www.accessdata.fda.gov/cdrh_docs/pdf4/K041530.pdf schrijft:
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Predicate devices:
Erchonia K012580
Quantum system K032816
. . .

The Excalibur Light Therapy System is a non-heating lamp, infrared as described under the provisions
of 21 CFR §890.5500 and is clinically indicated for:
-- Adjunctive use in providing temporary relief of minor chronic neck and shodlder pain
of musculoskeletal origin.
As with the predicate device, pain therapy treatment can be prescribed for pain associated with
with the clinical presentation specified above by having the beams pulsed or continuous with time considerations.
The Excalibur Light Therapy System's variables conform to the performance specifications of
the clinical parameters used by the predicate devices in frequency, wavelength, time, and power output,

De FDA-clearances beschrijven de toepassingsgrenzen.
Zie ook een verwant apparaat, dat teruggrijpt op dezelfde voorgangers: http://skepp.be/apparatuur/grt-lite

Geen afbeelding.