Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- NZYLight, Lymphedema Reduction, Low Energy2Product Code
- OAPLaser, Comb, Hair2Product Code
- K252414Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)2Cleared 510(K)
- K252325Hair Growth Laser Cap2Cleared 510(K)
- K251017CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)2Cleared 510(K)
- K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)2Cleared 510(K)
- K250308Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)2Cleared 510(K)
- K242747FAQ™ (302)2Cleared 510(K)
- K242619GroWell BT Hair Growth System (GW10042)2Cleared 510(K)
- K242363HIGHERDOSE Red Light Hat (HG-120K)2Cleared 510(K)
- K241342Hair Growth Comb (SZ-23,SZ-23A)2Cleared 510(K)
- K242620Breo Laser Hair Growth Comb (Scalp 3L)2Cleared 510(K)
- K240472PBM Hair Therapy Cap2Cleared 510(K)
- K240689Robin's Egg2Cleared 510(K)
- K242441Revian Lyte (10011)2Cleared 510(K)
- K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap2Cleared 510(K)
- K240064Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom2Cleared 510(K)
- K232356Laser Cap, Model: Hat-012Cleared 510(K)
- K231321Nooance Led And Laser Helmet2Cleared 510(K)
- K231153Neuhat Hair Growth System; ibeauty.com Laser Cap2Cleared 510(K)
- K222790F65 Laser System2Cleared 510(K)
- K230134Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-0022Cleared 510(K)
- K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)2Cleared 510(K)
- K223862Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp2Cleared 510(K)
- K230336CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)2Cleared 510(K)
- K222477Hair Growth Device2Cleared 510(K)
- K222364Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)2Cleared 510(K)
- K222081ID-510 iRestore Elite2Cleared 510(K)
- K213789Intelligence LaserComb2Cleared 510(K)
- K213027Laser Hair Growth Comb2Cleared 510(K)
- K213025Laser hair growth helmet2Cleared 510(K)
- K220543Auxo A300, A150 and APod2Cleared 510(K)
- K213447LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.2Cleared 510(K)
- K213094ID-500 iRestore Hair Growth System2Cleared 510(K)
- K211192Grivamax Family of Lasers, Models 272 and 1482Cleared 510(K)
- K211038Biophotas Celluma RESTORE2Cleared 510(K)
- K210169Hair Growth Device2Cleared 510(K)
- K203826LaserCap Family of Lasers 300, 224, 120 & 802Cleared 510(K)
- K202983easy Hairfull2Cleared 510(K)
- K202631iHelmet Laser Comb2Cleared 510(K)
- K193008Tricoglam Home Use2Cleared 510(K)
- K201854CAPOGEN Laser Cap2Cleared 510(K)
- K200464LG Pra. L Derma LD Scalp Care2Cleared 510(K)
- K200929Hair Growth System2Cleared 510(K)
- K192552Irradiation Cosmetic Device2Cleared 510(K)
- K193667Shapiro MD model laser 2722Cleared 510(K)
- K192585Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap2Cleared 510(K)
- K190467iHelmet Hair Growth System2Cleared 510(K)
- K192627Laser Hair Growth Cap2Cleared 510(K)
- K191754Hair Growth System2Cleared 510(K)
- K192425Hair Boom 69, Hair Boom Air, Ulike Hair UpUp2Cleared 510(K)
- K192012Capillus 112, Capillus 2442Cleared 510(K)
- K191154Hair Boom 692Cleared 510(K)
- K190685Hair Growth System2Cleared 510(K)
- K183417iRestore Professional 2822Cleared 510(K)
- K183329Laser Hair Therapy2Cleared 510(K)
- K182562Hair Boom 692Cleared 510(K)
- K182501Hair Laser Headband2Cleared 510(K)
- K181878Kiierr 272 Laser, Kiierr 148 Laser2Cleared 510(K)
- K181308SuperGrow 272, Ultimate 2722Cleared 510(K)
- K181253Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup2Cleared 510(K)
- K180885HairMax Laser2Cleared 510(K)
- K180617Hair Up2Cleared 510(K)
- K180460Theradome LH402Cleared 510(K)
- K173846DermaScalp Laser Cap2Cleared 510(K)
- K173729REVIAN RED2Cleared 510(K)
- K173678Diode Laser Cap2Cleared 510(K)
- K171835Irradiation Aesthetic Device2Cleared 510(K)
- K173843illumiflow 148 Laser Cap2Cleared 510(K)
- K171775Theradome LH80 PRO2Cleared 510(K)
- K172968Hair Up2Cleared 510(K)
- K172982SuperGrow 272, Ultimate 2722Cleared 510(K)
- K171895Grivamax Hair Growth System2Cleared 510(K)
- K162782iHelmet Hair Growth System2Cleared 510(K)
- K162071IllumiFlow Laser Cap2Cleared 510(K)
- K163170Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 3522Cleared 510(K)
- K162994Capillus302, Capillus312, Capillus3522Cleared 510(K)
- K161875LaserCap300, LaserCap224, LaserCap120, LaserCap802Cleared 510(K)
- K160728NutraStim Hair Laser Helmet2Cleared 510(K)
- K161046Laser Helmet LH40-EVO2Cleared 510(K)
- K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus2022Cleared 510(K)
- K152587DermaScalp Laser Cap2Cleared 510(K)
- K153618Capillus2022Cleared 510(K)
- K151662iRestore2Cleared 510(K)
- K152019HairMD2Cleared 510(K)
- K151516Capillus822Cleared 510(K)
- K150613LaserCap LC Pro and LC Elite2Cleared 510(K)
- K150578Capillus 272 Office Pro2Cleared 510(K)
- K142824LX-100 Hair Growth Stimulation System2Cleared 510(K)
- K143199Capillus 272 Pro2Cleared 510(K)
- K141588NUTRA STIM HAIR LASER COMB2Cleared 510(K)
- K141596NUTRA STIM HAIR LASER COMB2Cleared 510(K)
- K140931IGROW II HAIR GROWTH SYSTEM2Cleared 510(K)
- K142573HairMax LaserComb, HairMax LaserComb2Cleared 510(K)
- K141567IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM2Cleared 510(K)
- K132646SUNETICS CLINICAL BIO-STIMULATION LASER2Cleared 510(K)
- K121920LASERBRUSH2Cleared 510(K)
- K122950LASER HELMET2Cleared 510(K)
- K122248IGROW II HAIR GROWTH SYSTEM2Cleared 510(K)
- K113097LASER HELMET2Cleared 510(K)
- K112524HAIRMAX LASERCOMB2Cleared 510(K)
- K111714HAIRMAX DUAL 122Cleared 510(K)
- K110233HAIRMAX LASERCOMB2Cleared 510(K)
- K103368HAIRMAX LASERCOMB2Cleared 510(K)
- K091496MEP-90 HAIR GROWTH STIMULATION SYSTEM2Cleared 510(K)
- K093499HAIRMAX LASERCOMB2Cleared 510(K)
- K060305HAIRMAX LASERCOMB2Cleared 510(K)
- OZCOver The Counter Thermal Treatment For Acne.2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
LASER HELMET
- Page Type
- Cleared 510(K)
- 510(k) Number
- K113097
- 510(k) Type
- Traditional
- Applicant
- THERADOME INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/2/2012
- Days to Decision
- 135 days
- Submission Type
- Summary