FDA releases May 2016 510(k) clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2016 TOTAL 510(k)s THIS PERIOD 213 TOTAL WITH SUMMARIES 205 TOTAL WITH STATEMENTS 8 May 2016 510(k) Clearances SHARE TWEET LINKEDIN PIN IT EMAIL PRINT 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD May 2016 DEVICE: O-PEP PARI RESPIRATORY EQUIPMENT, INC. 510(k) NO: K150044(Traditional) ATTN: Michael Judge PHONE NO : 1 804 2537274 2412 PARI Way SE DECISION MADE: 27-MAY-16 Midlothian VA 23112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERBE ESU Model VIO dV with Accessories ERBE ELEKTROMEDIZIN GMBH 510(k) NO: K150364(Traditional) ATTN: Axel Retzlaff PHONE NO : 49 7071 70755349 WALDHOERNLESTRASSE, 17 SE DECISION MADE: 05-MAY-16 TUEBINGEN DE 72072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Filbloc ASSUT EUROPE 510(k) NO: K150553(Traditional) ATTN: GLORIA AGGIO PHONE NO : 39 06 72677348 ZONA INDUSTRIALE SE DECISION MADE: 19-MAY-16 MAGLIANO DEI MARSI IT 1-67062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINPOINT Endoscopic Fluorescence Imaging System NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K150956(Traditional) ATTN: TIM VERSPAGEN PHONE NO : 604 232 9861 240 13155 DELF PLACE, UNIT 250 SE DECISION MADE: 23-MAY-16 RICHMOND CA V6V 2A2 510(k) SUMM...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news

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Authors: García-García Á, Melián R, Carreras H, Rodríguez-Hernández V, Reñones J, Estévez B Abstract AIM: To determine the agreement and to compare the measurements obtained from a colour light-emitting diode based (CassiniTM) and Scheimpflug (PentacamTM) based topography in the evaluation of the anterior, posterior, and total corneal power and astigmatism. METHODS: A total of 30 eyes from 30 healthy patients were consecutively measured using PentacamTM and CassiniTM. The main evaluated parameters were the anterior, posterior, and total dioptric power, and...
Source: Archivos de la Sociedad Espanola de Oftalmologia - Category: Opthalmology Tags: Arch Soc Esp Oftalmol Source Type: research
ConclusionsKeratometry measurement with Nidek ARK-510A was not significantly different from Pentacam and Lenstar, and this device can be used in screening programs in emmetropes.ResumenObjetivoDeterminar la concordancia y validez de las mediciones queratométricas en niños con el autorefractoqueratómetro Nidek ARK-510A, comparadas con las imágenes de Scheimpflug con Pentacam y el biómetro Lenstar LS 900.MétodosEste estudio se realizó en 5.620 niños, de edades comprendidas entre 6 y 12 años, en Shahroud, Irán. Se compararon los valores queratométric...
Source: Journal of Optometry - Category: Opthalmology Source Type: research
ian M Abstract PURPOSE: To assess the preoperative visual, refractive, corneal topo/tomographic, aberrometric and biomechanical parameters as predictive factors of a successful outcome 6 months following intrastromal corneal ring segments implantation. METHODS: 68 keratoconus eyes implanted with Keraring using femtosecond laser technology were assessed. The preoperative assessed parameters included uncorrected and corrected distance visual acuity (UDVA &CDVA), refraction, placido-based topography using TMS-4, Scheimplfug tomography using Pentacam HR, corneal biomechanical assessments using Ocular Response...
Source: Current Eye Research - Category: Opthalmology Authors: Tags: Curr Eye Res Source Type: research
Authors: Kay AB Abstract Thomas Wharton Jones (1808-91), described as a 'genius' by his famous pupil Thomas Henry Huxley, was an Edinburgh medical graduate. At the age of 19 years he was appointed anatomy demonstrator to the infamous Dr Robert Knox so unwittingly becoming caught up in the Burke and Hare scandal. Escaping to Glasgow, and then to Cork and London, Jones eventually became an outstanding physiologist and ophthalmologist. His seminal observations included scholarly treatises on the vasculature in inflammation together with descriptions of the contractile movement of white blood cells, as well as studies ...
Source: Journal of the Royal College of Physicians of Edinburgh - Category: General Medicine Tags: J R Coll Physicians Edinb Source Type: research
Probing depth and system aberrations have direct impacts on the spatial resolution of stimulated emission depletion (STED) microscopes. Based on the vectorial diffraction theory, the influence of coma and astigmatism on the focal patterns of STED microscopes in probing stratified mediums with ...
Source: Applied Optics - Category: Physics Authors: Source Type: research
Ocular complications with significant reduction in visual acuity are common in MPS patients. Diagnostic problems may arise in these patients with severe corneal opacification, especially for those with MPS VI and MPS I. AbstractBackgroundMucopolysaccharidoses (MPSs) are a group of rare lysosomal storage disorders characterized by the accumulation of glycosaminoglycans in various tissues and organs. Ocular problems that affect the cornea, trabecular meshwork, sclera, retina, and optic nerve are very common in these patients. However, there was limited literature focusing on comprehensive ocular findings in different types o...
Source: Molecular Genetics & Genomic Medicine - Category: Genetics & Stem Cells Authors: Tags: ORIGINAL ARTICLE Source Type: research
Abstract BACKGROUND: Mucopolysaccharidoses (MPSs) are a group of rare lysosomal storage disorders characterized by the accumulation of glycosaminoglycans in various tissues and organs. Ocular problems that affect the cornea, trabecular meshwork, sclera, retina, and optic nerve are very common in these patients. However, there was limited literature focusing on comprehensive ocular findings in different types of MPS. METHODS: We retrospectively reviewed the clinical ophthalmologic features and electrodiagnostic results of 50 Taiwanese patients with a diagnosis of MPS (34 males and 16 females; age range, 1.1-34...
Source: Molecular Medicine - Category: Molecular Biology Authors: Tags: Mol Genet Genomic Med Source Type: research
rid-Costa D Abstract PURPOSE:: To assess the outcomes of implanting Ferrara-type intrastromal corneal ring segments in central 'bow-tie'-shaped keratoconus over 3 years of follow-up. METHODS:: A total of 20 eyes with central 'bow-tie'-shaped keratoconus were evaluated before and after implanting Ferrara-type intrastromal corneal ring segments (AJL Ophthalmic, Spain). LogMAR uncorrected distance visual acuity and best corrected distance visual acuity and residual refractive errors analysed using vector analysis were recorded preoperatively, at 6 months, 1 year, and 3 years postopera...
Source: European Journal of Ophthalmology - Category: Opthalmology Authors: Tags: Eur J Ophthalmol Source Type: research
Conclusions: The pattern and location of thinning without findings consistent with inflammatory disease suggest that the partial bilateral scleral rupture was because of mechanical damage at the time of LASIK, possibly compounded by the hormonal changes of pregnancy.
Source: Cornea - Category: Opthalmology Tags: Case Report Source Type: research
Conclusions: Peripheral pneumatic dissection and central scar peeling technique is a useful technique to complete DALK in eyes with scars due to previous hydrops.
Source: Cornea - Category: Opthalmology Tags: Techniques Source Type: research
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