FDAFDA · Alimentos y medicamentos·N.º oficial Z-1599-2013
Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538
Publicado el 3 de julio de 2013 · Inicio del retiro: 9 de mayo de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may confuse user.
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- ConBio, a CynoSure Company
- Distribuidor
- Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and Chile.
- Lote
- 659-1050-585 nm Handpiece; Manufacturer numbers: 659-1050 / C13B1141 659-1050 / D13C1151 659-1050 / D13C1157 659-1050 / D13C1158 659-1050 / D13C1160 659-1050 / D13C1154 Model 659-1100 - 650 nm Handpiece; manufacturer numbers: 659-1100 / C13B1141 659-1100 / D13C1151 659-1100 / D13C1157 659-1100 / D13C1158 659-1100 / D13C1160 659-1100 / D13D1165.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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