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Latest HairMax LaserComb Stories

2012-07-13 23:02:31

Lexington Int´l announces the creation of the ℠SWITCH´ Program, which offers a discount for purchase of the HairMax LaserComb® for men with hereditary hair loss who wish to switch treatment from oral drugs to the non-drug treatment, the HairMax LaserComb. Boca Raton, FL (PRWEB) July 13, 2012 Lexington Int´l manufacturers of the home use laser phototherapy medical device, the HairMax LaserComb is pleased to announce the launch of a new sales program to provide those...

2011-11-03 07:00:00

An analysis undertaken to assess the safety and efficacy of the HairMax LaserComb from 6 double blind clinical studies with 460 subjects found that no serious side effects occurred in any of these studies which proved the efficacy of the device in treating androgenetic alopecia (hereditary hair loss) in men and women. This analysis combined with the fact that there have never been any reports of serious side effects occurring in the over 10 years the HairMax has been on the market,...

2011-10-21 07:00:00

Lexington Int'l announces that FDA Marketing Clearance has been granted for the HairMax Advanced 7 and Professional 12 models, for the treatment of androgenetic alopecia (hereditary hair loss) in females.This latest milestone is the culmination of Lexingtonâs goal to offer a complete line of innovative, cutting edge, phototherapy devices for treating hereditary hair loss in men and women around the world. Boca Raton, FL (PRWEB) October 21, 2011 Lexington International, LLC, is...

2011-08-15 09:53:00

SILVER SPRING, Md., Aug. 15, 2011 /PRNewswire-USNewswire/ -- For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Released today, the guidance focuses on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices. The recommendations made in the guidance are...

2011-07-26 08:54:00

SILVER SPRING, Md., July 26, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The 510(k) process is the most common review path to market for lower-risk medical devices. To legally market a device, manufacturers must submit a premarket notification or 510(k)...

2011-06-23 00:00:31

An examination of publicly available FDA data by Emergo Group on 510(k) clearances over the last five years indicates that 80% of devices receive clearance within six months. Austin, TX (PRWEB) June 22, 2011 Emergo Group, an Austin-based consulting firm that assists medical device manufacturers with regulatory compliance, has completed a comprehensive analysis of medical device 510(k) submissions cleared by the US Food and Drug Administration (FDA). Most Class 2 devices, and some Class 1...

2011-04-21 08:00:00

BOCA RATON, Fla., April 21, 2011 /PRNewswire/ -- Lexington International, LLC is pleased to announce that it has successfully completed 2 clinical studies of the HairMax LaserComb proving the efficacy and safety of 3 new devices for the treatment of androgenetic alopecia (hereditary hair loss). The analysis showed that 95.4% of participants using the HairMax LaserComb experienced hair growth. Furthermore, the average increases in hair count for participants in the HairMax LaserComb group...

2011-02-14 23:00:16

Most medical devices recently recalled by the Food and Drug Administration because of very serious risks were initially approved through an expedited process or were exempt from regulatory review, according to a report posted online today that will be published in the June 14 print issue of Archives of Internal Medicine, one of the JAMA/Archives journals. "Unlike prescription drugs, medical devices are reviewed by the U.S. Food and Drug Administration (FDA) using two alternative regulatory...

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2011-01-20 07:15:26

The US Food and Drug Administration (FDA) announced Wednesday it plans to update its 35-year-old system that is used to approve most medical devices, which has come under increased criticism from public safety advocates. The agency announced several changes it plans to make this year, including reorganizing the review process for some low-risk devices. But regulators said they will delay a decision on most drastic proposals, which would give the government more power over device makers. The...

2011-01-13 13:02:00

Company cited for significant manufacturing violations SILVER SPRING, Md., Jan. 13, 2011 /PRNewswire-USNewswire/ -- U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, on Jan. 5 and 6, seized all dental devices from Rite-Dent Manufacturing Corporation, located in Hialeah, Fla. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The seizure of dentistry products valued at $208,910 follows an FDA inspection that found significant...


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