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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lightwave Technologies, LLC 1/3/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900 

 

WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
                                                                                                                                   
January 3, 2013                                                                                                                           WL # 13-13                                                                                                            
 
Micheal E. Poling, President
Lightwave Technologies, LLC
1734 W. William Drive, Suite 10
Phoenix, Arizona   850270-1260
 
Dear Mr. Poling:
 
During an inspection of your firm located in Phoenix Arizona,on September 17 through September 21, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Lightwave devices, marketed as the Lightwave Deluxe L.E.D., the Lightwave Professional L.E.D., and the Lightwave Elite L.E.D. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
 
Our inspection revealed that the Lightwave devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The Lightwave devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k) and 21 C.F.R. 807.81(a)(3)(ii).  Specifically, the Lightwave Professional Deluxe (K082586) was cleared under section 510(k) of the Act, 21 U.S.C. § 360(k) for the following intended uses:
 
  • Red Light: dermatology, for treatment of superficial, benign vascular and pigmented lesions.
  • Red and Blue Light combination: dermatological conditions; specifically acne vulgaris, and the treatment of periorbital wrinkles.
  • Blue Light: dermatological conditions; specifically moderately inflammatory acne vulgaris.
  • Infrared Light: to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. 
 
However, a review of your device design and labeling for the Lightwave devices revealed that your firm has been marketing these devices for intended uses including treatments for stretch marks, cellulite, hair loss, and hair restoration.  
 
For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency.  [21 CFR 807.81(b)]  The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default. htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements between October 1st and December 31st of the year 2011 and as of December 21, 2012, your firm has still not completed its required annual registration.
 
Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
 
Your firm should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts
 
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your firm’s response should be sent to: Mr. Blake Bevill, Director, Compliance Branch, Food and Drug Administration, 19701 Fairchild, Irvine, California 92612. If you have any questions about the content of this letter please contact: Dr. William Vitale at 949-608-2919.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.  Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.  
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc: 
Ms. Ingeborg Small, Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
P.O. Box 997435
Sacramento, CA 95899-7435