HairMax LaserComb Advanced 7, Lux 9 and Professional 12 Males
Contents
1. Performance Testing Testing to IEC 60601 1 and 60601 1 2 confirm the device s adherence to LVD electrical and EMC safety requirements Testing to IEC 60825 confirm the laser classification to be Class 3R same as predicate devices Clinical Testing Two randomized double blind controfled multi center clinical trials were conducted to confirm the performance of the subject devices These studies confirm that the subject devices are expected to provide an effective dose rate to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types I to IV with safety and effectiveness outcomes substantially equivalent to those of the predicate devices Additionally a study was conducted to validate the HairMax LaserComb User Manual Copyright 2009 for the Lux 9 Professtonal 12 beam unit and confirm usability Participants in the study were given access to the HairMax LaserComb and the User Manual under controlled conditions Based on the study outcomes the device and manual were validated within a sample population that could potentially desire to use the HairMax LaserComb Lexington International LLC 12 November 16 2010 HairMax LaserComb Advanced 7 Lux 9 and Professional 12 510k Premarket Application Substantial Equivalence The HairMax LaserComb Advanced 7 HairMax Lux 9 and HairMax Professional 12 are as safe and effective as the p2. Indications for Use Statement 510 k Number To be assigned Device Name HairMax LaserComb Advanced 7 HairMax LaserComb Lux 9 and HairMax LaserComb Professional 12 Indications for Use The HairMax LaserComb Advanced 7 is indicated to treat androgenetic alopecia promote hair growth and help prevent further hair loss in males who have Norwood Hamilton Classifications of lla to V patterns of hair loss and Fitzpatrick Skin Types I to IV The HairMax LaserComb Lux 9 is indicated to treat androgenetic alopecia promote hair growth and help prevent further hair loss in mates who have Norwood Hamilton Classifications of Ha to V patterns of hair toss and Fitzpatrick Skin Types I to IV The HairMax LaserComb Professional 12 is indicated to treat androgenetic alopecia promote hair growth and help prevent further hair loss in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types I to IV Prescription Use AND OR Over The Counter Use ___X Part 21 CFR 801 Subpart D 21 CFR 807 Subpart C PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH Office of Device Evaluation ODE Q i Division Sign Off Division of Surgical Orthopedic and Restorative Devices 510 k Number K 03368 om Page iof_ t Lexington International LLC 10 November 16 2010
3. forth in the quality systems QS regulation 21 CFR Part 820 and if applicable the electronic product radiation control provisions Sections 531 542 of the Act 21 CFR 1000 1050 If you desire specific advice for your device on our labeling regulation 21 CFR Part 801 please go to http www fda gov A boutF DA CentersOffices CDRH CDRHOffices ucm 15809 htm for the Center for Devices and Radiological Health s CDRH s Office of Compliance Also please note the regulation entitled Misbranding by reference to premarket notification 21CFR Part 807 97 For questions regarding the reporting of adverse events under the MDR regulation 21 CFR Part 803 please go to http www fda gov MedicalDevices Safety ReportaProblem default htm for the CDRH s Office of Surveillance and Biometrics Division of Postmarket Surveillance You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers International and Consumer Assistance at its toll free number 800 638 2041 or 301 796 7100 or at its Internet address http www fda gov Medical Devices Resourcesfor Y ou Industry default btm Dr yours if hn f j Mark N Melkerson Director Division of Surgical Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure HairMax LaserComb Advanced 7 Lux 9 and Professional 12 510k Premarket Application Section 4
4. HairMax LaserComb Advanced 7 Lux 9 and Professional 12 Males 510 k 103368 FDA Clearance to Market April 6 2011 K133 ey HairMax LaserComb Advanced 7 Lux 9 and Professional 12 510k Premarket Application APR 6 2011 Section 5 510 k Summary The following information is provided as required by 21 CFR 807 87 for Lexington International LLC HairMax LaserComb Advanced 7 HairMax LaserComb Lux 9 and HairMax LaserComb Professional 12 510 k premarket notification In response to the Safe Medical Devices Act of 1990 the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based Sponsor Lexington International LLC 777 Yamato Rd Suite 105 Boca Raton FL 33431 Contact Olsson Frank Weeda Casper E Uldriks Esq 1400 Sixteenth Street NW Suite 400 Washington DC 20036 Ph 202 518 6385 culdriks ofwlaw com Date of Submission November 16 2010 Proprietary Name HairMax LaserComb Advanced 7 HairMax LaserComb Lux 9 and HairMax LaserComb Professional 12 Common Name Lamp non heating for promotion of hair growth Regulatory Class Il Product Codes OAP Predicate Device s Lexington International LLC HairMax LaserComb K060305 and K093499 Device Description Substantially equivalent to the HairMax LaserComb K060305 K093499 the modified HairMax LaserComb Advanced 7 HairMax Lux 9 and HairMax Professional 12 are hand held low level laser devic
5. a premarket approval application PMA You may therefore market the device subject to the general controls provisions of the Act The general controls provisions of the Act include requirements for annual registration listing of devices good manufacturing practice labeling and prohibitions against misbranding and adulteration Please note CDRH does not evaluate information related to contract liability warranties We remind you however that device labeling must be truthful and not misleading If your device is classified see above into either class II Special Controls or class III PMA it may be subject to additional controls Existing major regulations affecting your device can be found in the Code of Federal Regulations Title 21 Parts 800 to 898 In addition FDA may publish further announcements concerning your device in the Federal Register Page 2 Casper E Uldriks Esq Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies You must comply with all the Act s requirements including but not limited to registration and listing 21 CFR Part 807 labeling 21 CFR Part 801 medical device reporting reporting of medical device related adverse events 21 CFR 803 good manufacturing practice requirements as set
6. es that emits laser light with the intention to promote hair growth The devices provide distributed laser light to the scalp while the comb teeth simultaneously part the user s hair to ensure the laser light reaches the user s scalp HairMax LaserComb Advanced 7 HairMax Lux 9 and HairMax Professional 12 replace the cleared version s Lexington International LLC i November 16 2010 HairMax LaserComb Advanced 7 Lux 9 and Professional 12 510k Premarket Application single beam laser and beam splitting reflector with a circuit board containing seven nine or twelve laser diodes respectively Intended Use The HairMax LaserComb Advanced 7 HairMax Lux 9 and HairMax Professional 12 are indicated to treat androgenetic alopecia promote hair growth and help prevent further hair loss in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types to IV Technological Characteristics The HairMax LaserComb Advanced 7 HairMax Lux 9 and HairMax Professional 12 consist of a hand held low level laser devices that promotes hair growth The device provides distributed laser light to the scalp while the device s comb teeth simultaneously part the user s hair to ensure the laser light reaches the user s scalp When in use the device emits a beep 9 and 2 laser models or vibration 7 laser model every four seconds to notify the user to move the device to a new section of the scalp
7. redicate devices The HairMax LaserComb Advanced 7 HairMax Lux 9 and HairMax Professional 12 have the same intended use of promoting hair growth as the predicate devices The subject devices have the same general indications ie treating androgenetic alopecia and the same specific indication of promoting hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of 1 to V patterns of hair loss as the predicate devices Except for modifications to the laser delivery method and slight increases in laser output the HairMax LaserComb Advanced 7 HairMax Lux 9 and HairMax Professional 12 is identical in technological characteristics as the HMLC as cleared in K060305 and K093499 including its red laser wavelength its comb component its instructions for use and its audible or vibrating timer The modification to the HairMax LaserComb Advanced 7 HairMax Lux 9 and HairMax Professional 12 does not change the intended use of the product nor does it affect the products fundamental scientific technology Therefore this change does not raise new questions of safety or effectiveness This was also demonstrated in randomized double blind control clinical studies evaluating changes in terminal hair count in the evaluation zone as well as usability studies to validate instructions for use confirm that device modifications do not affect the safe and effective use of the devices when compared to the predicates For those reason
8. s the HairMax LaserComb Advanced 7 HairMax Lux 9 and HairMax Professional 12 satisfy FDA s substantial equivalence with respect to both the intended use and technological characteristics Lexington International LLC 13 November 16 2010 a SERVICES r Or l K DEP CRT MENT OF BEALE S HUMAN SERVICES Public Health Service atg 4 Food and Drug Administration 10903 New Hampshire Avenue Document Control Room WO66 G609 Silver Spring MD 20993 0002 Lexington International LLC Olsson Frank Weeda Casper E Uldriks Esq APR 6 204 1400 Sixteenth Street NW Washington District of Columbia 20036 Re K103368 Trade Device Name HairMax LaserComb Advanced 7 HairMax LaserComb Lux 9 and HairMax LaserComb Professional 12 Regulation Number 21 CFR 890 5500 Regulation Name Infrared lamp Regulatory Class Class II Product Code OAP Dated January 26 2011 Received March 15 2011 Dear Mr Uldriks We have reviewed your Section 510 k premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent for the indications for use stated in the enclosure to legally marketed predicate devices marketed in interstate commerce prior to May 28 1976 the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food Drug and Cosmetic Act Act that do not require approval of
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