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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To conduct Fourier analysis on regular and irregular astigmatism of the anterior and posterior corneal surfaces using anterior segment optical coherence tomography in patients with Fuchs endothelial corneal dystrophy (FECD).
Source: American Journal of Ophthalmology - Category: Opthalmology Authors: Tags: Original Articles Source Type: research
This study aimed to evaluate the long-term visual quality after microincision cataract surgery (MICS). Methods: 96 patients (144 eyes) diagnosed with age-related cataracts were enrolled in this one-year study. The patients underwent MICS and received aspheric monofocal intraocular lens implants. Uncorrected distance visual acuity (UDVA) was evaluated together with best-corrected distance visual acuity (BCDVA), best-corrected near visual acuity (BCNVA), contrast sensitivity, and surgically induced astigmatism (SIA). Results: Compared to preoperative measurements, UDVA, BCDVA, and BCNVA were significantly better after surgery (P
Source: Journal of Ophthalmology - Category: Opthalmology Tags: J Ophthalmol Source Type: research
CONCLUSION: SMILE is a predictable and safe technique for the surgical correction of astigmatism. Manual compensation may be an effective approach to improve astigmatic outcomes of SMILE, especially in moderate and high astigmatism. PMID: 33004196 [PubMed - as supplied by publisher]
Source: Journal Francais d Ophtalmologie - Category: Opthalmology Tags: J Fr Ophtalmol Source Type: research
Abstract BACKGROUND/AIMS: To report the 10-year outcomes of modified microkeratome-assisted lamellar keratoplasty (LK) for keratoconus. METHODS: In this single-centre interventional case series, 151 consecutive eyes with keratoconus underwent modified microkeratome-assisted LK. Eyes with scars extending beyond the posterior half of the corneal stroma and preoperative thinnest-point pachymetry value of less than 300 μm were excluded. Outcome measures were best spectacle-corrected visual acuity (BSCVA), refractive astigmatism (RA), endothelial cell density, immunological rejection, ectasia recurrence an...
Source: The British Journal of Ophthalmology - Category: Opthalmology Authors: Tags: Br J Ophthalmol Source Type: research
Précis: The ultrasound ciliary plasty (UCP) procedure affects corneal parameters, although the effect is transient. Ultrasound energy affects the sclera, leading to induced astigmatism. The area of energy application correlates with the astigmatism axis. Purpose: To assess the postoperative corneal topography for 1 year after UCP. Materials and Methods: In total, 78 patients with primary and secondary refractory glaucoma were enrolled in the study. The primary outcome measures were the corneal parameters obtained with anterior segment swept-source optical coherence tomography. Intraocular pressure, number of...
Source: Journal of Glaucoma - Category: Opthalmology Tags: Original Studies Source Type: research
CONCLUSION: Lentis Comfort IOLs provided better visual function at far and intermediate distances. PMID: 32999178 [PubMed - as supplied by publisher]
Source: Journal of Nippon Medical School - Category: Universities & Medical Training Authors: Tags: J Nippon Med Sch Source Type: research
CONCLUSION: In this simulation study the effect of a combination of lens decentration in horizontal direction and tilt with respect to the vertical axis on defocus, astigmatism and horizontal coma was analyzed. The results may help to describe in clinical routine if with a decentered or tilted artificial lens implant the postoperative refraction does not match the target refraction or the resulting astigmatism after cataract surgery is not fully explained by measurement of corneal astigmatism. PMID: 32997197 [PubMed - as supplied by publisher]
Source: Der Ophthalmologe - Category: Opthalmology Authors: Tags: Ophthalmologe Source Type: research
We present two patients with keratoconus who referred to our department after a PKP combined with the implantation of an intrastromal ring. The first patient suffered from bulbar pain and headaches. The second patient suffered from postoperative high myopia, irregular astigmatism and was contact lens intolerant. In the first patient we recognized anterior movement of the ring inside the stroma and decided to remove it. The second patient was found to have extreme bulging of the transplant. We removed the ring and sequentially performed a repeat-PKP. In both patients the implantation of the ring failed to decrease the posto...
Source: European Journal of Ophthalmology - Category: Opthalmology Authors: Tags: Eur J Ophthalmol Source Type: research
Title: What Type of LASIK is Best for Astigmatism?Category: Diseases and ConditionsCreated: 9/25/2020 12:00:00 AMLast Editorial Review: 9/25/2020 12:00:00 AM
Source: MedicineNet Eyesight General - Category: Opthalmology Source Type: news
Title: What Is the Best Way to Correct Astigmatism?Category: Diseases and ConditionsCreated: 9/25/2020 12:00:00 AMLast Editorial Review: 9/25/2020 12:00:00 AM
Source: MedicineNet Eyesight General - Category: Opthalmology Source Type: news
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