FDAFDA · Alimentos y medicamentos·N.º oficial Z-3110-2026
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system may be configured with an Intelligent Cooling Device (ICD) to provide epidermal cooling during laser treatment
Publicado el 16 de septiembre de 2026 · Inicio del retiro: 6 de agosto de 2026
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Lutronic Corporation
- Distribuidor
- Worldwide distribution - US Nationwide and the countries of Canada and European Union.
- Lote
- Lot Code: Model: DermaV Software Version: 1.06 UDI #: 08800291820200 Serial Numbers: DV025A010, DV025A011, DV025A012, DV025A013, DV025A014, DV025A015 DV025A016, DV025A018, DV025A019, DV025A020, DV025A021, DV025A022, DV025B011, DV025B012, DV025B013, DV025B014, DV025B015, DV025D006, DV025D007, DV025D008, DV025D009, DV025D010, DV025E003, DV025E004, DV025E005, DV025E006, DV025E007, DV025E008, DV025E009, DV025E010, DV025E011, DV025E012, DV025E013, DV025E014, DV025E016, DV025E017, DV025F012, DV025F013, DV025F014, DV025F015, DV025F016, DV025G011, DV025G012, DV025G013, DV025G014, DV025G015, DV025G016, DV025G017, DV025G018, DV025G019, DV025G020, DV025J021, DV025J022, DV025J023, DV025J025, DV025J026, DV025J027, DV025J028, DV025J034, DV025J035, DV025J036, DV025J037, DV025J038, DV025J040, DV025K018, DV025K019, DV025K020, DV025K021, DV025K023, DV025K024, DV025K025, DV025K027, DV025M031, DV025M032, DV025M033, DV025M034, DV026B001, DV026B002, DV026B003, DV026B004, DV026B005, DV026B010, DV026B014, DV026B015, DV026B016, DV026B017, DV026B018, DV026C006, DV026C007, DV026C008, DV026C009, DV026C010, DV025M035
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Korea (the Republic of)
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