Thursday, October 20, 2011
New FDA Clearance for the HairMax LaserComb Fills an Unmet Need of Providing an Effective, Non-drug Home-use Device For Treating Hair Loss.
Boca Raton, FL. (Oct 19, 2011) - Lexington International, LLC, is pleased to announce that the company has received FDA 510(k) #K112524 Marketing Clearance for two new models of the HairMax LaserComb®, laser phototherapy medical device for the treatment of hereditary hair loss in women.
FDA Clearance Letter Link:
Hereditary hair loss is a devastating condition affecting over 30 million women in the United States. Until recently, when the HairMax Lux 9 was initially FDA Cleared for marketing for treatment of females, there had been only one FDA approved drug for treating this condition in women. This latest FDA Clearance now expands the HairMax treatment options for the three of the HairMax LaserComb models, as an effective first-line treatment of hereditary hair loss in both men and women. This is the fourth FDA 510(k) Clearance for marketing granted to Lexington Int’l this year.
The HairMax LaserComb cordless models that are now available are the HairMax Advanced 7, the HairMax Lux 9, and the HairMax Professional 12. These devices are offered at varying price points which fit the needs of all people wishing to treat their hair loss condition. The HairMax is easy and convenient to use with treatments at home of just 9-15 minutes per day, three times per week to achieve results, which can be seen in as little as 12 weeks. Also, the HairMax is safe to use, as no serious side effects have ever been reported from use of the HairMax.
This FDA marketing Clearance for females combined with prior FDA marketing Clearance for males, provides the following official indication for the HairMax LaserComb.
The HairMax Advanced 7, Lux9, and the Professional 12 models are indicated to treat Androgenetic Alopecia, and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V and in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and who both have Fitzpatrick Skin Types I to IV.
This latest milestone is the culmination of Lexington’s goal to offer a complete line of innovative, cutting edge, phototherapy devices for treating hereditary hair loss in men and women around the world. These testimonials from satisfied users of the HairMax are typical of the numerous comments we have received: “It got to the point that I wasn’t going out much anymore. I noticed that when I spoke to my relatives and friends they weren’t looking directly at me – they were looking at my hairline and that made me feel even more self-conscious about my hair loss.” And, “HairMax has rejuvenated my hair growth, my self-esteem and my confidence”.
Link to Other testimonials: http://www.hairmax.com/lasercomb-reviews-testimonials
In four double-blind clinical studies on the treatment of androgenetic alopecia (hereditary hair loss) in both men and women over 93% of subjects in the HairMax LaserComb groups experienced hair growth at 6 months. These results were consistent in all studies showing that the results with the HairMax are reproducible and predictable. Since 2001, Lexington has completed a total of seven clinical studies with 460 subjects. All of the studies (including these four), have conclusively proven that the HairMax LaserComb family of products are efficacious and safe as first line therapy for appropriate classes of hereditary hair loss.
Mr. David Michaels, Managing Director of Lexington said, “We have spent 11 years of R&D, innovation, and the completion of seven clinical studies to bring these innovative products to market. This recent FDA marketing Clearance brings to fruition our goal of offering a complete line of laser phototherapy products for people who are suffering from hereditary hair loss. Our challenge now is not how to get there, but how to assure that we get this information about the HairMax out to the millions of people suffering from this devastating condition”.
Randy Veliky, Lexington COO said: “This recent FDA Clearance means that the HairMax LaserComb with its patented technology and state of the art design, now solidifies the position of Lexington as the world-wide leader in the treatment of hair loss. No other company marketing a device of its kind for hair loss matches the breadth, scope, and depth of our product line.”
About Lexington International, LLC
Based in Boca Raton, Lexington International is a manufacturer and developer of advanced medical laser devices to treat hair loss and scalp disorders. Lexington Int’l markets the only laser phototherapy device with published clinical trial results proving efficacy and safety in a peer review journal. The company received the 2009 U.S. President’s “E” Award, recognizing successes in world markets. The Medical Advisory Board of the company is comprised of world-wide authorities in the treatment of hair loss and scalp disorders. Over the past 11 years and in over 155 countries worldwide, Lexington has helped hundreds of thousands of individuals treat their hair condition and enrich their lives.
Friday, September 30, 2011
We have now teamed up with SortPrice.com to offer you with top of the line products at bottom line prices.
Sortprice.com has quickly become one of the most popular shopping search engines on the internet and an emerging leader in the e-commerce industry.
Sortprice is designed for everyone from the seasoned online shopper to the apprehensive first-timer. Our innovative features and advanced search technology, coupled with one of the largest selections of products and retailers online, make it easy to browse items and compare prices on everything from MP3 players to diamond rings to baby strollers.
With our unique "Shop, Drag and Drop" feature, detailed product reviews, enhanced product images, and the ability to search for products by brand, store, price and color, Sortprice is committed to building the best online shopping tool that no shopper should be without!
Our mission is simple. We help consumers save money by offering them the safest and easiest online shopping experience available, while providing merchants with a fair and cost-effective way to expand their online sales presence.
We are proud to announce our partnership with Sears, you can now find all of the great products Balkowitsch Enterprises offers on Sears.com a name you have known for decades! Please click on the Sear logo above to visit or newly designed store!
Sears Holdings Corporation (NASDAQ: SHLD) is the nation's fourth largest broadline retailer with over 4,000 full-line and specialty retail stores in the United States and Canada. Sears Holdings is the leading home appliance retailer as well as a leader in tools, lawn and garden, consumer electronics and automotive repair and maintenance. Sears Holdings is the 2011 ENERGY STAR® Retail Partner of the Year. Key proprietary brands include Kenmore, Craftsman and DieHard, and a broad apparel offering, including such well-known labels as Lands' End, Jaclyn Smith and Joe Boxer, as well as the Apostrophe and Covington brands. It also has the Country Living collection, which is offered by Sears and Kmart. We are the nation's largest provider of home services, with more than 11 million service calls made annually. Sears Holdings Corporation operates through its subsidiaries, including Sears, Roebuck and Co. and Kmart Corporation.
Check out our new facebook store! You can now browse our great collection of products from your favorite website Facebook. If you call and place your order over the phone today and mention of FACEBOOK STORE we will take $5 off your purchase. Give us a call today (800)355-2956.
Monday, May 16, 2011
Balkowitsch Enterprises, Inc. became the Master U.S. Distributor for the Prestige Classic 2100 Autoclave starting in January of this year. Our goal is to provide excellent service and continue to educate the public on the huge health risks involved with going to an Nail Salon that does not autoclave their instruments between clients.
Please follow our Facebook page about the Prestige Classic 2100 Autoclave and nail salon safety guidelines and practices.
Labels: Nail Salon Safety
Thursday, January 27, 2011
G5 Esthetic Facial Beauty Spa Face Wand Massager. The G5 is the professional grade brand used by professional athletes, physical therapists, massage therapists, spa's, resorts and respiratory therapists and is also found in the clinical environment. An invaluable tool for assisting in the facial massage process. This great massager works perfect when used in the 6-Steps outlined below! The G5 Esthetic Wand is a gentle, quiet, Directional-Stroking model designed specifically for facial applications. The Esthetic Massager is small enough for easy portability and is powered by a single "C" cell replaceable battery, and weighs less than five ounces. Comes with two (2) Directional-Stroking® disposable applicators and one vibration applicator. We also back every G5 that we sell with our 100% money back guarantee. If you have any questions please call us at (701)223-9936 or Toll Free (800)355-2956.
- Soft rubber end cushions unit in the event of a fall.
- Red Arrow indicates the direction of fluid movement.
- Comes with three different applicators.
- Output Speed - 40 cycles per second
- Power Source - 1.5 volt DC
- Speed Control - Single Switch On/Off
- Housing Material - ABS Cycolac
- Configurations - Hand-held
- Unit Dimensions - 6” H x 1.25” W x 1.25” D
- Unit Weight - 6 oz.
- Includes Applicator Package w/ 3 different heads
G5™ Brand Medical Devices, G5 Brand Percussors and G5 Brand Massage Machines are recognized as the most Powerful, Reliable, and Durable in the world. For more than 45 years the G5 Brand has served the medical massage needs of Respiratory Therapy, Physical Therapy, Chiropractic, Sports Medicine and Spa & Salon segments of the medical marketplace.
Thursday, January 13, 2011
Balkowitsch Enterprises, Inc. has negotiated to be the Master Distributor for the Prestige Classic 2100 Autoclave out of the United Kindgom
On January 1st, Balkowitsch Enterprises, Inc. has negotiated to be the Master Distributor for the Prestige Classic 2100 Autoclave out of the United Kindgom. Balkowitsch enterprises has sold thousands of these autoclaves over the year and this new agreement opens the door to better distribution of this product throughout the United States. If you would like to be a distributor of the Prestige Autoclave please contact us at (800)355-2956.