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Black Durette® Plastic External Shields, regular

Oculo-Plastik Inc · Model 23-445B · UDI-DI 10697660003372

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Durette Plastic External Shields are intended to protect patient’s eyes from apparatuses emitting different wavelengths of non coherent light. They should not be used with Lasers THAT IRRADIATE A COHERENT LIGHT BEAM (spectral irradiance of any wavelength) OR ANY FLASH LAMP OR IPL SYSTEM THAT operates in burst modes that comprise multiple trains of pulses. THEY SHOULD NOT BE USED with high-power, spectral irradiance in the UVB and UVA wavebands or any other spectral irradiance energy or light source. THE DURETTE PLASTIC EXTERNAL SHIELDS can be used with: * Light emitted by fluorescent lamps, bright LEDs or dichroic filament bulbs. * VISIBLE VIOLET LIGHT IN THE RANGE OF 405-420. * Light therapy for skin conditions like psoriasis or eczema which use UVA or UVB PHOTOTHERAPY. * PUVA TREATMENT. * LIGHT THERAPY by Red and/or near infrared (NIR) LEDs. * Photodynamic Therapy (PDT) light sources. * Narrowband Light emitting Diodes (LEDs) - Optimised, via a matrix of LEDs.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.