BEUDAMED
    Product Code: OHT FDA class 2 21 CFR 878.4810

    Light Based Over-The-Counter Hair Removal

    General, Plastic Surgery

    The Light Based Over-The-Counter Hair Removal device is a consumer-use device that applies thermal energy from light sources to kill hair follicles, achieving hair reduction or removal without requiring a prescription or clinical setting. Classified as FDA Class 2 under regulation 21 CFR 878.4810 within the General, Plastic Surgery medical specialty, it requires a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is OHT. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    162
    FEI Numbers
    90
    Registration Numbers
    91
    Unique Applicants
    83
    Years Active
    19

    Basic Information

    Product Code
    OHT
    Device Class
    FDA class 2
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Over-the-counter device uses thermal energy to kill hair follicles for hair removal.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 162 510(k) clearances via K numbers.

    K Number Device Name
    K261325 Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
    K260594 IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)
    K260742 Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
    K260518 IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)
    K254047 Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)
    K253666 IPL Hair Removal Device (Models: T31A, T32A)
    K253881 Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
    K253754 Philips Lumea IPL
    K253304 IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
    K253035 IPL Hair Removal Device (SYL001AZ, SYL002AZ)
    K252618 IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
    K252234 IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)
    K252209 IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)
    K251398 IPL Hair Removal Device (IPL-001, IPL-002)
    K252804 Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL,
    K251914 IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)
    K251176 IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
    K251707 IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
    K251984 Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
    K251173 Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
    K250942 Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
    K251000 Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
    K243036 IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)
    K250938 Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)
    K250384 IPL400
    K250253 IPL Hair Removal Device (KCA511/KCA516/KCA522)
    K243017 IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)
    K250194 Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
    K250171 IPL Hair Removal Device (BE965A, BE965B, BE965C)
    K250131 IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
    K243453 Philips Lumea IPL
    K243085 IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)
    K241998 Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
    K242710 Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
    K243362 SmoothSkin Pure Switch (SSC1)
    K242595 Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
    K242039 Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
    K243030 Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
    K242197 IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
    K241834 IPL Hair Removal Device (BE932C, BE932D, BE932E)
    K241205 Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
    K241881 IPL Hair Removal Device (JM-843, JM-865, JM-638)
    K240016 IPL Hair Removal Device (YT01,YT02,YT03,YT04)
    K241343 IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)
    K241120 Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
    K240649 Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
    K240583 IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)
    K240969 IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)
    K241106 Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
    K240093 IPL Home Use Hair Removal Device (SJ15)
    K240652 Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
    K240282 IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)
    K240587 SmoothSkin Pure Unplugged (SSB3)
    K240264 Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)
    K233887 IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
    K233664 IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,)
    K233679 IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)
    K233782 SmoothSkin Pure Adapt (SSG3)
    K232939 IPL Hair Removal Device
    K232846 Light Based Hair Removal Device
    K232932 Intense Pulse Light Therapeutic Apparatus
    K232575 Hair Removal Device, Model(s): R2815-G Pro, R2815-G
    K232845 IPL Cooling Hair Removal Device
    K232499 IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
    K232056 IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002
    K232274 IPL hair removal device
    K231977 PEACH 2, PEACH 2 Duo, PEACH 2 go
    K232183 IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
    K232124 IPL Hair Removal, Model: W-1095, W-1098
    K230362 Planar LED mate
    K231800 IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
    K231717 IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
    K231613 Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
    K230025 IVYLASER Handhold Hair Removal Machine
    K231215 IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
    K230473 IPL Hair Removal Device Models: MLY-T069
    K230739 Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
    K230911 Braun Skin i.expert
    K230549 IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
    K230090 Diode Laser Hair Removal
    K230360 IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
    K230122 IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
    K230097 IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
    K230107 Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
    K230021 IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
    K223928 Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
    K230060 Light Based Hair Removal Device GP592
    K223618 IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
    K223524 IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
    K222710 IPL Cooling Hair Removal Device
    K222598 IPL Hair Removal Device
    K221643 Hair Removal Device (Model: IPL-D26, IPL-D19)
    K222537 IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
    K222432 IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
    K222316 IPL Hair Removal Device
    K221553 Diamond Air+ (UI04A, UI04B, UI04C)
    K221635 IPL sapphire ice cooling hair remove device
    K221466 IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
    K221451 IPL hair removal
    K221679 IPL Hair Remover, Model: G993, G996, G998 and G885
    K221246 IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)
    K220248 Home use hair removal device
    K221569 Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
    K220927 IPL Hair Removal
    K221002 IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
    K220669 IPL HAIR REMOVAL HANDSET, Model: IPL-666
    K221001 IPL Home Use Hair Removal Device
    K220645 Hand-held IPL device (JOVS Hair Removal Device)
    K220222 IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
    K212881 Intense Pulsed Light (IPL) System
    K214113 Hand-held IPL device(JOVS Graphene Hair Removal Device)
    K213830 Home use hair removal device, model: Precise Touch Pro
    K213692 SmoothSkin Pure Mini
    K212318 IPL Hair Removal
    K211185 IPL Home Use Hair Removal Device
    K213020 IPL hair removal machine
    K212697 Leaf Smooth
    K213041 IPL Hair Removal, Model: OBT-02
    K212897 IPL Hair Removal Device, model: AI01
    K212314 IPL Hair Removal Device
    K210376 Superior Hair Remover
    K211922 IPL Home Use Hair Removal Device
    K211174 IPL Hair Removal
    K211994 Braun Silk.expert Mini
    K210311 Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
    K203510 IPL Hair removal
    K200184 SmoothSkin Pure
    K192432 IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
    K190820 Aimanfun Lumea Comfort
    K192010 SmoothSkin BARE+
    K190366 BRAUN Silk Expert Pro 3
    K190354 BRAUN Silk.expert Pro 5
    K183260 Sensilight Pro / Pistol IPL
    K183217 IPL Hair Removal Device
    K181734 Beurer IPL 8500 device/ IPL VelvetSkin Pro
    K181568 IPL Salon Hair Reduction System
    K173813 IPL Hair Removal Device Joy Version
    K181121 Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
    K180383 Light based hair removal device
    K180016 Home Use IPL Beauty Device
    K172883 Home Use Hair Removal Device/T1, T2, T3
    K172791 Lumilisse IPL Hair Remover
    K172181 micro IPL
    K171433 Silk'n Infinity
    K170269 Hee HR Mini
    K161428 PerfectSmooth
    K163552 iPulse SmoothSkin BARE Hair Removal Device
    K163173 Handheld Diode Laser for Hair Removal
    K162231 iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
    K161089 sensiLight Mini
    K160968 iPulse SmoothSkin Gold Hair Removal Device
    K142845 SILKPRO laser hair removal system
    K143003 iPulse Smooth Skin Gold Hair Removal System
    K141242 GLIDE DEVICE
    K132518 NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
    K140381 SENSILIGHT/ SENSILIGHT PLUS
    K140527 SENSILIGHT MINI
    K131870 GLIDE DEVICE
    K130315 IPULSE HAIR REMOVAL SYSTEM
    K122280 IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM
    K103184 SILK'N FLASH N GO
    K060839 ABC HAIR REMOVAL SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 90 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 91 registration numbers. Click on an entry to view related FDA registrations.