CDRH promo untitled letters.

The following untitled letters were issued by the Promotion and Advertising Staff of the Center for Devices, Office of Compliance (CDRH-OC) in 2001. Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval.

11755W & 11756W

Allied Health Association, Eaglewood, CO, July 11 & 26, 2001 (CDRH-OC). A review of the association's pro-motional materials for use of the Tri-Phasic Resonator led FDA to request "all product labeling and promotional material currently...being distributed." Allied's East Arapahoe Court address received the first letter and the firm's South Akron Street address received the second letter.

11757W

Allways Electrolysis, Huntsville, AL, July 18, 2001 (CDRH-OC). The firm's advertisements make a claim that the Candela GentleLASE laser can perform "Permanent FDA Appoved Laser Hair Removal." FDA states the la-ser was cleared for "photocoagulation of dermatological vascular lesions and for temporary hair reduction,."and that permanent hair reduction does not equate with permanent hair removal, a claim which the agency called "misleading."

11758W

Custom Ultrasonics, Ivyland, PA, July 23, 2001 (CDRH-OC). Web site promotional material for the firm's System 83 Plus washer-disinfector stated it was "the only FDA cleared automated Washer/Disinfector." The agency stated "that there are other FDA-cleared automated endoscope reprocessors and cleared medical washers and washer-disinfectors for general medical devices."

11759W

Cynosure, Inc., Chelmsford, MA, July 18, 2001 (CDRH-OC). Print and Web site promotional materials for the firm's Photogenica series of lasers made claims that the devices could be used to treat wrinkle reduction, skin rejuventation, reduction of pore size and stimulation of collagen production--all uses that had not received FDA approval, the agency stated. Web

11760W

Dornier Medical Systems, Kennesaw, GA, July 18, 2001 (CDRH-OC). The letter followed on the heels of a March 14, 2001 letter (11560W) concerning off-label claims of its Medilas D 940 nm diode laser. FDA stated it has continued to receive complaints that the firm has promoted the device at seminars and workshops for the endovenous treatment of varicose veins.

11761W

Laser Vision Correction Center & Corneal Service, New York, NY, July 10, 2001 (CDRH-OC). FDA took issue with the center's radio ad for the Sunrise Hyperion LTK laser which stated "Are you over 40 years of age and unhappy about wearing reading glasses or contact lenses?...A brand new technology just approved by the FDA can help you throw away your glasses..."(cf. Doc. 11654W). Additionally, FDA raised the validity of Laser Thermal Keratoplasty video footage on the firm's Web site. Essentially, the agency stated the LTK is a temporary procedure and that the firm's omission of the term "temporary" was misleading. Web

11762W

New York Eye Specialists, New York, NY July 20, 2001 (CDRH-OC). The practice's print and Web site promotional materials claims that "Wide beam technology" of the Bausch & Lomb Technolas 217 "reduces night vision problems." FDA stated it does not know what the practice means by "wide beam technology". Also, FDA stated that Web site data for the VISX Star S3 were not correct or "accurately presented." Web

11763W

Southeastern Biofeedback and Neurobehavioral Institute, Knoxville, TN, July 9, 2001 (CDRH-OC). Similar to a letter delivered to Stoelting Company, July 6, 2001 (Doc. 11683W), the agency took issue with Southeastern's Web site promoting workshops on Stoelting's A620 Biofeedback device to treat Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD) when the device was only cleared for relaxation training only. Web

11764W

Surgin, Inc., Tustin, CA, June 27, 2001 (CDRH-OC). The letter responded to the firm through the firm's attorney, Robert Dormer of the Washington, DC firm Hyman, Phelps & McNamara, referring to a May 31, 2001 response to the agency letter dated April 23, 2001 (Doc. 11599W). The agency originally cited the firm for marketing its Prizm Microkeratome blades as replacement blades for competing devices when the firm was only cleared to market its Accublade keratomes as a replacement for Chiron blades. The firm stated through counsel that it determined that it merely needed to change the shape of the blade and did not require a new 510(k) based on its interpretation of the guidance entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device." FDA stated Surgin erred in this determination and that an "incorrect fit in the keratome may cause serious adverse events" such as uneven cuts, shallow cuts, too deep cuts, or free flaps. Web

11765W

Tillotson Healthcare, Bedford, NH, July 5, 2001 (CDRH-OC). The letter updated the letter issued June 14, 2001 (Doc. 11655W) acknowledging the firm's June 19 response. The agency had continuing concerns with the firm's use of the phrase "10ug/g of antigenic protein" in the marketing of their Ultra Preserve latex gloves. While the agency acknowledged that the reference referred "to the ELISA test method compared to the Lowry Test Method," it went on to state that the agency did not recognize this as an official test method. FDA urged the firm to remove all references to the 10ug/g antigenic protein claim on its Web site. Web

11766W

Tyco HealthCare Group, Pleasnton, CA, Aug. 6, 2001 (CDRH-OC). While the FDA approved of Tyco's decision to remove the word "HEPA" from its Sterivent line of breathing filters, the agency objected to the firm's assertion "that it is reasonable to continue to ship the product with the current labels."

11767W

Winthrop, Stuart, MD, FACS, Santa Barbara, CA, July 17, 2001 (CDRH-OC). The agency stated the practice's claim that with Autonomous' LADARVision laser's eye tracking technology "you don't have to worry about holding still!" is misleading. The agency stated that patients must still fixate on a blinking target when being treated with the device. Also, since the practice advertises the VISX Star S3 laser along with the LADARVision, it must provide specific risk information in promotional materials, the letter stated.

11768W

Wu, Wilson, M.D., Ph.D, Santa Barbara, CA, July 10, 2001 (CDRH-OC). FDA cited the practice for mentioning the VISX Star S3 and Autonomous LADARVision lasers in a newspaper ad for the practice without including a brief statement of the intended uses of the devices.