[pending] Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but
Pending LLM rewrite. Source: FDA_DEVICE Z-2295-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Some of the Calibration/Output Certificates had the outputs reversed.
The recalled product
- Product
- Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4
- Manufacturer
- Daavlin Distributing Company
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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