60 results
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7ms
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Sources: EU EUDAMED, US FDA
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5¿15 mm¿ and 14.5¿25.5 mm¿. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed. Component: NO
FDA Enforcement
Class II
·Completed·LEASEIR TECHNOLOGIES SLU·January 28, 2026
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·January 31, 2024
RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·August 26, 2015
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
FDA Enforcement
Class II
·Terminated·Sedecal S.A.·March 16, 2016
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131; g) 95 Multichroma 14LA2, REF GC00157; h) 95 Multichroma 20LB2, REF GC00098; i) 95 Multichroma 20LBL2, REF GC00114; j) 95 Multichroma 16LA3,5, REF GC00132; k) 95 Multichroma 14LA1, REF GC00158; l) 95 Multichroma 24LB1, REF GC00099; m) 95 Multichroma 20LA3,5, REF GC00115; n) 95 Multichroma 16LA3, REF GC00133; o) 95 Multichroma 16LC2, REF GC00091; p) 95 Multichroma 14LBL2, REF GC00134; q) 95 Multichroma 24LBL2, REF GC00092; r) 95 Multichroma 24LA3,5, REF GC00101; s) 95 Multichroma 20LA3, REF GC00117; t) 95 Multichroma 14LB1, REF GC00135; u) 95 Multichroma 24LB2, REF GC00094; v) 95 Multichroma 20LA2, REF GC00119; w) 95 Multichroma14LA3,5, REF GC00137; x) 95 Multichroma 14LC2, REF GC00095; y) 95 Multichroma 24LA3, REF GC00104; z) 95 Multichroma14LA3, REF GC00138 ; used in the manufacture of dentures.
FDA Enforcement
Class II
·Ongoing·GRAPHENANO DENTAL SL·March 6, 2024
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·March 8, 2023
Phoenix mKDR, digital mobile diagnostic x-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·March 8, 2023
SM_40HF_BDC3, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
SM_40HF_BDC, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
SM_40HF_B_D_VIR3.004, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
SHIMADZU RF.004, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number 40KWMOBILE3.899, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
SED URS LP, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number 40KWFXPLUS.889, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number 40KW-FX.899, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number 40KWFXPLUS.004, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Sedecal NOVA FA DR System. for diagnostic radiography.
FDA Enforcement
Class II
·Ongoing·Sedecal S.A.·November 28, 2018
Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
FDA Enforcement
Class II
·Ongoing·SEDECAL SA·October 29, 2025