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
- EMFKnife, Surgical1Product Code
- EPTMicroscope, Surgical1Product Code
- EPWSupport, Head, Surgical, Ent1Product Code
- OEJTransurethral Electrosurgical Unit, Benign Prostatic Hyperplasia2Product Code
- FAZSystem, Cryosurgical, Liquid Nitrogen, For Urology2Product Code
- OEKWater-Induced Thermotherapy System, Benign Prostatic Hyperplasia2Product Code
- GAGStapler, Surgical2Product Code
- DWGElectrosurgical Device2Product Code
- DWHBlade, Saw, Surgical, Cardiovascular1Product Code
- DWISaw, Electrically Powered1Product Code
- DWONeedle, Biopsy, Cardiovascular1Product Code
- QQSStapler, Skin1Product Code
- BTAPump, Portable, Aspiration (Manual Or Powered)2Product Code
- BWAUnit, Electrosurgical And Coagulation, With Accessories2Product Code
- BWNTable And Attachments, Operating-Room1Product Code
- BWPShoe And Shoe Cover, Conductive1Product Code
- FGYCannula, Injection1Product Code
- FHMApparatus, Suturing, Stomach And Intestinal1Product Code
- FHRNeedle, Gastro-Urology1Product Code
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature2Product Code
- FNWPad, Kelly2Product Code
- FQOTable, Operating-Room, Ac-Powered1Product Code
- FQPLamp, Operating-Room2Product Code
- FSETable, Operating-Room, Manual1Product Code
- FSHTray, Surgical, Needle1Product Code
- FSMTray, Surgical, Instrument1Product Code
- FSOMicroscope, Surgical, General & Plastic Surgery1Product Code
- FSPLoupe, Diagnostic/Surgical1Product Code
- FSQLight, Surgical, Instrument2Product Code
- FSSLight, Surgical, Floor Standing2Product Code
- FSTLight, Surgical, Fiberoptic2Product Code
- FSWLight, Surgical, Endoscopic2Product Code
- FSXLight, Surgical, Connector2Product Code
- FSYLight, Surgical, Ceiling Mounted2Product Code
- FSZLight, Surgical, Carrier2Product Code
- FTALight, Surgical, Accessories2Product Code
- FTCLight, Ultraviolet, Dermatological2Product Code
- FTDLamp, Surgical2Product Code
- FTFIlluminator, Non-Remote2Product Code
- FTGIlluminator, Remote2Product Code
- FTHCamera, Still, Microsurgical1Product Code
- FTSCamera, Cine, Endoscopic, With Audio1Product Code
- FTTCamera, Still, Surgical1Product Code
- FTXMirror, General & Plastic Surgery1Product Code
- FTYTape, Measuring, Rulers And Calipers1Product Code
- FWBCamera, Television, Surgical, Without Audio1Product Code
- FWCCamera, Television, Surgical, With Audio1Product Code
- FWDCamera, Television, Microsurgical, Without Audio1Product Code
- FWECamera, Television, Microsurgical, With Audio1Product Code
- FWFCamera, Television, Endoscopic, Without Audio1Product Code
- FWGCamera, Television, Endoscopic, With Audio1Product Code
- FWHCamera, Cine, Surgical, Without Audio1Product Code
- FWICamera, Cine, Surgical, With Audio1Product Code
- FWJCamera, Cine, Microsurgical, Without Audio1Product Code
- FWKCamera, Cine, Microsurgical, With Audio1Product Code
- FWLCamera, Cine, Endoscopic, Without Audio1Product Code
- FWWTable, Operating-Room, Pneumatic1Product Code
- FWXTable, Operating-Room, Mechanical1Product Code
- FWYTable, Operating-Room, Non-Electrical1Product Code
- FWZOperating Room Accessories Table Tray1Product Code
- FXMCamera, Still, Endoscopic1Product Code
- FXNTape, Camera, Surgical1Product Code
- FXQLens, Camera, Surgical1Product Code
- FXRHolder, Camera, Surgical1Product Code
- FXSFrame, Camera, Surgical1Product Code
- FXTFilm, Camera, Surgical1Product Code
- FXWShoes, Operating-Room1Product Code
- FYEDress, Surgical1Product Code
- FYFCap, Surgical1Product Code
- FZKChair, Surgical, Non-Electrical1Product Code
- FZMStool, Operating-Room1Product Code
- FZOChisel, Surgical, Manual1Product Code
- FZPClip, Implantable2Product Code
- FZQClip, Removable (Skin)1Product Code
- FZRContractor, Surgical1Product Code
- FZSCurette, Surgical, General Use1Product Code
- FZTCutter, Surgical1Product Code
- FZWExpander, Surgical, Skin Graft1Product Code
- FZXGuide, Surgical, Instrument1Product Code
- FZYHammer, Surgical1Product Code
- FZZMarker, Skin1Product Code
- GAANeedle, Aspiration And Injection, Disposable1Product Code
- GABNeedle, Suturing, Disposable1Product Code
- GACRasp, Surgical, General & Plastic Surgery1Product Code
- GADRetractor1Product Code
- GAESnare, Surgical1Product Code
- GAFSpatula, Surgical, General & Plastic Surgery1Product Code
- GAHStylet, Surgical, General & Plastic Surgery1Product Code
- GAIStripper, Vein, Reusable1Product Code
- GAJStripper, Vein, Disposable1Product Code
- GAKSuture, Absorbable2Product Code
- GALSuture, Absorbable, Natural2Product Code
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid2Product Code
- GANSuture, Absorbable, Synthetic2Product Code
- GAOSuture, Nonabsorbable2Product Code
- GAPSuture, Nonabsorbable, Silk2Product Code
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile2Product Code
- GARSuture, Nonabsorbable, Synthetic, Polyamide2Product Code
- GASSuture, Nonabsorbable, Synthetic, Polyester2Product Code
- GATSuture, Nonabsorbable, Synthetic, Polyethylene2Product Code
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene2Product Code
- GBACatheter, Balloon Type1Product Code
- GBBChair, Surgical, Ac-Powered1Product Code
- GBCLamp, Surgical, Incandescent2Product Code
- GBNCatheter, Pediatric, General & Plastic Surgery1Product Code
- GBOCatheter, Nephrostomy, General & Plastic Surgery1Product Code
- GBPCatheter, Multiple Lumen1Product Code
- GBQCatheter, Continuous Irrigation1Product Code
- GBSCatheter, Ventricular, General & Plastic Surgery1Product Code
- GBWCatheter, Peritoneal1Product Code
- GBXCatheter, Irrigation1Product Code
- GBYCatheter, Eustachian, General & Plastic Surgery1Product Code
- GBZCatheter, Cholangiography1Product Code
- GCBNeedle, Catheter1Product Code
- GCCDilator, Catheter1Product Code
- GCDConnector, Catheter1Product Code
- GCEAdaptor, Catheter1Product Code
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1Product Code
- GCZRetainer, Surgical1Product Code
- GDCTable, Operating-Room, Electrical1Product Code
- GDFGuide, Needle, Surgical1Product Code
- GDGHook, Surgical, General & Plastic Surgery1Product Code
- GDHGouge, Surgical, General & Plastic Surgery1Product Code
- GDIDissector, Surgical, General & Plastic Surgery1Product Code
- GDJClamp, Surgical, General & Plastic Surgery1Product Code
- GDLNeedle, Suturing, Reusable1Product Code
- GDMNeedle, Aspiration And Injection, Reusable1Product Code
- GDNKnife, Amputation1Product Code
- GDOApplier, Surgical, Clip1Product Code
- GDRSaw, Manual And Accessories1Product Code
- GDTStaple, Removable (Skin)1Product Code
- GDWStaple, Implantable2Product Code
- GDXScalpel, One-Piece1Product Code
- GDYGauze/Sponge, Internal, X-Ray Detectable1Product Code
- GDZHandle, Scalpel1Product Code
- GEACannula, Surgical, General & Plastic Surgery1Product Code
- GECBrush, Scrub, Operating-Room1Product Code
- GEDBrush, Dermabrasion, Manual1Product Code
- GEEBrush, Biopsy, General & Plastic Surgery1Product Code
- GEFApplier, Staple, Surgical,1Product Code
- GEGElevator, Surgical, General & Plastic Surgery1Product Code
- GEHUnit, Cryosurgical, Accessories2Product Code
- GEIElectrosurgical, Cutting & Coagulation & Accessories2Product Code
- GEJCarrier, Ligature1Product Code
- GENForceps, General & Plastic Surgery1Product Code
- GEOFile, Surgical, General & Plastic Surgery1Product Code
- GESBlade, Scalpel1Product Code
- GETMotor, Surgical Instrument, Pneumatic Powered1Product Code
- GEXPowered Laser Surgical Instrument2Product Code
- GEYMotor, Surgical Instrument, Ac-Powered1Product Code
- GFABlade, Saw, General & Plastic Surgery, Surgical1Product Code
- GFBHead, Surgical, Hammer1Product Code
- GFCDriver, Surgical, Pin1Product Code
- GFDDermatome1Product Code
- GFEBrush, Dermabrasion, Powered1Product Code
- GFFBur, Surgical, General & Plastic Surgery1Product Code
- GFGBit, Surgical1Product Code
- GFIOsteotome, Manual1Product Code
- GFJMallet, Surgical, General & Plastic Surgery1Product Code
- HABSaw, Powered, And Accessories1Product Code
- HAMApparatus, Electrosurgical2Product Code
- HBIIlluminator, Fiberoptic, Surgical Field2Product Code
- HBTApplier, Hemostatic Clip1Product Code
- HCFInstrument, Ligature Passing And Knot Tying1Product Code
- HJELamp, Fluorescein, Ac-Powered2Product Code
- HMPPad, Eye1Product Code
- HRBMicroscope, Operating, Non-Electric, Ophthalmic1Product Code
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic1Product Code
- HRQHemostat1Product Code
- HSOSaw1Product Code
- HTCPliers, Surgical1Product Code
- HTDForceps1Product Code
- HTEElevator1Product Code
- HTFCurette1Product Code
- HTRRasp1Product Code
- HTZInstrument, Cutting, Orthopedic1Product Code
- HWMOsteotome1Product Code
- HXDClamp1Product Code
- HXLMallet1Product Code
- HXRSpatula, Orthopedic1Product Code
- HXTTape, Orthopedic1Product Code
- HYAForceps, Wire Holding1Product Code
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered2Product Code
- JCYCatheter, Infusion1Product Code
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered1Product Code
- JEBTable, Surgical With Orthopedic Accessories, Manual1Product Code
- JOSElectrode, Electrosurgical2Product Code
- JOTElectrode, Gel, Electrosurgical2Product Code
- JYCCannula, Ear1Product Code
- JYDChisel, Mastoid1Product Code
- KAMCannula, Sinus1Product Code
- KANChisel, Nasal1Product Code
- KCECannulae, Bronchial1Product Code
- KDCInstrument, Surgical, Disposable1Product Code
- KDDKit, Surgical Instrument, Disposable1Product Code
- KDGChisel (Osteotome)1Product Code
- KFKSaw, Pneumatically Powered1Product Code
- KGLCabinet, Phototherapy (Puva)2Product Code
- KGSRetention Device, Suture1Product Code
- KGWRing (Wound Protector), Drape Retention, Internal2Product Code
- KGYBag, Intestine1Product Code
- KGZAccessories, Catheter1Product Code
- KIKHook, Bone1Product Code
- KOXSolvent, Adhesive Tape1Product Code
- KOYDegreaser, Skin, Surgical1Product Code
- KOZBeads, Hydrophilic, For Wound Exudate Absorption1Product Code
- KQMCamera, Surgical And Accessories1Product Code
- LEJBooth, Sun Tan2Product Code
- LMFAgent, Absorbable Hemostatic, Collagen Based3Product Code
- LMGAgent, Absorbable Hemostatic, Non-Collagen Based3Product Code
- LROGeneral Surgery Tray2Product Code
- LRPTray, Surgical1Product Code
- LRWScissors, General, Surgical1Product Code
- LRYPunch, Surgical1Product Code
- LRZScrewdriver, Surgical1Product Code
- LSAVise, Bench, Surgical1Product Code
- LWGSurgical Table Cushion1Product Code
- LWKRazor, Surgical1Product Code
- LXKScrapper, Skin Specimen1Product Code
- LXZGuard, Instrument1Product Code
- LYVLabel Or Tag, Sterile1Product Code
- LZMGuard, Skin Graft1Product Code
- MCHClip, Hemostatic2Product Code
- MCZSuture Removal Kit1Product Code
- MDAElastomer, Silicone, For Scar Management1Product Code
- MDMInstrument, Manual, Surgical, General Use1Product Code
- MGOClosure, Wound, Adhesive1Product Code
- MIJNeedle, Tumor Localization1Product Code
- MJGDevice, Percutaneous, Biopsy1Product Code
- MKYSystem, Skin Closure1Product Code
- MOQBattery, Replacement, Rechargeable1Product Code
- MPNTissue Adhesive For The Topical Approximation Of Skin2Product Code
- MULGenerator, Electrosurgical, Coagulation, Cancer2Product Code
- MUUSystem, Suction, Lipoplasty2Product Code
- MVRDevice, Anastomotic, Microvascular2Product Code
- MWYSystem, Microwave, Hair Removal2Product Code
- MXGLamp, Uvc, (For Treating Skin And Wounds)2Product Code
- MXWSuture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)2Product Code
- NABGauze / Sponge,Nonresorbable For External Use1Product Code
- NACDressing, Wound, Hydrophilic1Product Code
- NADDressing, Wound, Occlusive1Product Code
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic1Product Code
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2Product Code
- NCAClip, Implantable, For Coronary Artery Bypass Graft (Cabg)2Product Code
- NEHAnchor, Fascial2Product Code
- NEUMarker, Radiographic, Implantable2Product Code
- NEWSuture, Surgical, Absorbable, Polydioxanone2Product Code
- NEYSystem, Ablation, Microwave And Accessories2Product Code
- NJCClip, Vas Deferens2Product Code
- NJUSuture, Nonabsorbable, Nitinol2Product Code
- NJZExtractor, Vein1Product Code
- NLKNeedle, Biopsy, Cardiovascular, Reprocessed1Product Code
- NLLStaple, Implantable, Reprocessed2Product Code
- NMJClip, Implantable, Reprocessed2Product Code
- NMTNeedle, Catheter, Reprocessed1Product Code
- NMUNeedle, Gastro-Urology, Reprocessed1Product Code
- NNABiopsy Device, Percutaneous, Reprocessed1Product Code
- NNCNeedle, Aspiration And Needle, Reprocessed1Product Code
- NRBWound Cleaner, Ultrasound2Product Code
- NRJUltrasound, Skin Permeation2Product Code
- NTBSystem, Ablation, Ultrasound And Accessories2Product Code
- NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed2Product Code
- NUVMassager, Vacuum, Light Induced Heating2Product Code
- NVHSuture, Knot, Mechanical2Product Code
- NVJApplicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women2Product Code
- NWFDrill, Battery Powered, Subungual Hematoma1Product Code
- NWJSuture, Recombinant Technology2Product Code
- NXFGas, Laser Generating1Product Code
- NYSWound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)2Product Code
- OABLow Energy Direct Current Thermal Ablation System2Product Code
- ODRElectrosurgical Patient Return Electrode2Product Code
- OEIDrainage Catheter With Antibiotic2Product Code
- OELLaser, Benign Prostatic Hyperplasia2Product Code
- OHOFirst Aid Kit Without Drug1Product Code
- OHSLight Based Over The Counter Wrinkle Reduction2Product Code
- OHTLight Based Over-The-Counter Hair Removal2Product Code
- K250194Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)2Cleared 510(K)
- K250171IPL Hair Removal Device (BE965A, BE965B, BE965C)2Cleared 510(K)
- K250131IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)2Cleared 510(K)
- K243453Philips Lumea IPL2Cleared 510(K)
- K243085IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)2Cleared 510(K)
- K241998Ice 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)2Cleared 510(K)
- K242710Hair 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)2Cleared 510(K)
- K243362SmoothSkin Pure Switch (SSC1)2Cleared 510(K)
- K242595Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)2Cleared 510(K)
- K242039Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)2Cleared 510(K)
- K243030Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)2Cleared 510(K)
- K242197IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)2Cleared 510(K)
- K241834IPL Hair Removal Device (BE932C, BE932D, BE932E)2Cleared 510(K)
- K241205Ice 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)2Cleared 510(K)
- K241881IPL Hair Removal Device (JM-843, JM-865, JM-638)2Cleared 510(K)
- K240016IPL Hair Removal Device (YT01,YT02,YT03,YT04)2Cleared 510(K)
- K241343IPL 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)2Cleared 510(K)
- K241120Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)2Cleared 510(K)
- K240649Ice 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)2Cleared 510(K)
- K240583IPL 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)2Cleared 510(K)
- K240969IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)2Cleared 510(K)
- K241106Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)2Cleared 510(K)
- K240093IPL Home Use Hair Removal Device (SJ15)2Cleared 510(K)
- K240652Ice 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)2Cleared 510(K)
- K240282IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)2Cleared 510(K)
- K240587SmoothSkin Pure Unplugged (SSB3)2Cleared 510(K)
- K240264Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)2Cleared 510(K)
- K233887IPL 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)2Cleared 510(K)
- K233664IPL 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,)2Cleared 510(K)
- K233679IPL 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)2Cleared 510(K)
- K233782SmoothSkin Pure Adapt (SSG3)2Cleared 510(K)
- K232939IPL Hair Removal Device2Cleared 510(K)
- K232846Light Based Hair Removal Device2Cleared 510(K)
- K232932Intense Pulse Light Therapeutic Apparatus2Cleared 510(K)
- K232575Hair Removal Device, Model(s): R2815-G Pro, R2815-G2Cleared 510(K)
- K232845IPL Cooling Hair Removal Device2Cleared 510(K)
- K232499IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)2Cleared 510(K)
- K232056IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM0022Cleared 510(K)
- K232274IPL hair removal device2Cleared 510(K)
- K231977PEACH 2, PEACH 2 Duo, PEACH 2 go2Cleared 510(K)
- K232183IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T102Cleared 510(K)
- K232124IPL Hair Removal, Model: W-1095, W-10982Cleared 510(K)
- K230362Planar LED mate2Cleared 510(K)
- K231800IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR92Cleared 510(K)
- K231717IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM0222Cleared 510(K)
- K231613Intense 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.2Cleared 510(K)
- K230025IVYLASER Handhold Hair Removal Machine2Cleared 510(K)
- K231215IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S2Cleared 510(K)
- K230473IPL Hair Removal Device Models: MLY-T0692Cleared 510(K)
- K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-2002Cleared 510(K)
- K230911Braun Skin i.expert2Cleared 510(K)
- K230549IPL 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-B509BG2Cleared 510(K)
- K230090Diode Laser Hair Removal2Cleared 510(K)
- K230360IPL Cooling Hair Removal Device, Model(s): NBB01, NBB022Cleared 510(K)
- K230122IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG2Cleared 510(K)
- K230097IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT1082Cleared 510(K)
- K230107Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-35882Cleared 510(K)
- K230021IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP322Cleared 510(K)
- K223928Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K2Cleared 510(K)
- K230060Light Based Hair Removal Device GP5922Cleared 510(K)
- K223618IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD2Cleared 510(K)
- K223524IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN032Cleared 510(K)
- K222710IPL Cooling Hair Removal Device2Cleared 510(K)
- K222598IPL Hair Removal Device2Cleared 510(K)
- K221643Hair Removal Device (Model: IPL-D26, IPL-D19)2Cleared 510(K)
- K222537IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi2Cleared 510(K)
- K222432IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA4392Cleared 510(K)
- K222316IPL Hair Removal Device2Cleared 510(K)
- K221553Diamond Air+ (UI04A, UI04B, UI04C)2Cleared 510(K)
- K221635IPL sapphire ice cooling hair remove device2Cleared 510(K)
- K221466IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI172Cleared 510(K)
- K221451IPL hair removal2Cleared 510(K)
- K221679IPL Hair Remover, Model: G993, G996, G998 and G8852Cleared 510(K)
- K221246IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)2Cleared 510(K)
- K220248Home use hair removal device2Cleared 510(K)
- K221569Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K2Cleared 510(K)
- K220927IPL Hair Removal2Cleared 510(K)
- K221002IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C2Cleared 510(K)
- K220669IPL HAIR REMOVAL HANDSET, Model: IPL-6662Cleared 510(K)
- K221001IPL Home Use Hair Removal Device2Cleared 510(K)
- K220645Hand-held IPL device (JOVS Hair Removal Device)2Cleared 510(K)
- K220222IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S42Cleared 510(K)
- K212881Intense Pulsed Light (IPL) System2Cleared 510(K)
- K214113Hand-held IPL device(JOVS Graphene Hair Removal Device)2Cleared 510(K)
- K213830Home use hair removal device, model: Precise Touch Pro2Cleared 510(K)
- K213692SmoothSkin Pure Mini2Cleared 510(K)
- K212318IPL Hair Removal2Cleared 510(K)
- K211185IPL Home Use Hair Removal Device2Cleared 510(K)
- K213020IPL hair removal machine2Cleared 510(K)
- K212697Leaf Smooth2Cleared 510(K)
- K213041IPL Hair Removal, Model: OBT-022Cleared 510(K)
- K212897IPL Hair Removal Device, model: AI012Cleared 510(K)
- K212314IPL Hair Removal Device2Cleared 510(K)
- K210376Superior Hair Remover2Cleared 510(K)
- K211922IPL Home Use Hair Removal Device2Cleared 510(K)
- K211174IPL Hair Removal2Cleared 510(K)
- K211994Braun Silk.expert Mini2Cleared 510(K)
- K210311Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.2Cleared 510(K)
- K203510IPL Hair removal2Cleared 510(K)
- K200184SmoothSkin Pure2Cleared 510(K)
- K192432IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-11302Cleared 510(K)
- K190820Aimanfun Lumea Comfort2Cleared 510(K)
- K192010SmoothSkin BARE+2Cleared 510(K)
- K190354BRAUN Silk.expert Pro 52Cleared 510(K)
- K190366BRAUN Silk Expert Pro 32Cleared 510(K)
- K183260Sensilight Pro / Pistol IPL2Cleared 510(K)
- K183217IPL Hair Removal Device2Cleared 510(K)
- K181734Beurer IPL 8500 device/ IPL VelvetSkin Pro2Cleared 510(K)
- K181568IPL Salon Hair Reduction System2Cleared 510(K)
- K173813IPL Hair Removal Device Joy Version2Cleared 510(K)
- K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro2Cleared 510(K)
- K180383Light based hair removal device2Cleared 510(K)
- K180016Home Use IPL Beauty Device2Cleared 510(K)
- K172883Home Use Hair Removal Device/T1, T2, T32Cleared 510(K)
- K172791Lumilisse IPL Hair Remover2Cleared 510(K)
- K172181micro IPL2Cleared 510(K)
- K171433Silk'n Infinity2Cleared 510(K)
- K170269Hee HR Mini2Cleared 510(K)
- K161428PerfectSmooth2Cleared 510(K)
- K163552iPulse SmoothSkin BARE Hair Removal Device2Cleared 510(K)
- K163173Handheld Diode Laser for Hair Removal2Cleared 510(K)
- K162231iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert2Cleared 510(K)
- K161089sensiLight Mini2Cleared 510(K)
- K160968iPulse SmoothSkin Gold Hair Removal Device2Cleared 510(K)
- K142845SILKPRO laser hair removal system2Cleared 510(K)
- K143003iPulse Smooth Skin Gold Hair Removal System2Cleared 510(K)
- K141242GLIDE DEVICE2Cleared 510(K)
- K132518NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE2Cleared 510(K)
- K140381SENSILIGHT/ SENSILIGHT PLUS2Cleared 510(K)
- K140527SENSILIGHT MINI2Cleared 510(K)
- K131870GLIDE DEVICE2Cleared 510(K)
- K130315IPULSE HAIR REMOVAL SYSTEM2Cleared 510(K)
- K122280IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM2Cleared 510(K)
- K103184SILK'N FLASH N GO2Cleared 510(K)
- K060839ABC HAIR REMOVAL SYSTEM2Cleared 510(K)
- OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption2Product Code
- OJJBurn Kit Without Drug1Product Code
- OJRVacuum Powered Body Fluid Collection Kit2Product Code
- OJTAspiration Tray1Product Code
- OJUSkin Prep Tray1Product Code
- OJVSingle Use Instrument Tray1Product Code
- OUHSkin Resurfacing Rf Applicator2Product Code
- OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite2Product Code
- OJWShave Prep Kit2Product Code
- OKJLight Based Treatment For Cold Sores Herpes Simplex Virus-12Product Code
- OKONegative Pressure Wound Therapy Non-Powered Suction Apparatus2Product Code
- OLPOver-The-Counter Powered Light Based Laser For Acne2Product Code
- OMDCutaneous Tissue Adhesive With Mesh2Product Code
- OMPNegative Pressure Wound Therapy Powered Suction Pump2Product Code
- ONEPowered Light Based Non-Laser Surgical Instrument2Product Code
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect2Product Code
- ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output2Product Code
- ONQElectrosurgical Coagulation For Aesthetic2Product Code
- OOKDermal Cooling Pack/Vacuum/Massager2Product Code
- ORECryogenic, Skin Tag Removal, Otc2Product Code
- ORKLaser Assisted Lipolysis2Product Code
- OTKWound Drain Catheter System2Product Code
- OUBInstrument For Treatment Of Hyperhidrosis2Product Code
- OVNSuture Kit2Product Code
- OXTPercutaneous Surgical Set With Attachments2Product Code
- OYWLaser, Cellulite Appearance2Product Code
- PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction2Product Code
- PBXMassager, Vacuum, Radio Frequency Induced Heat2Product Code
- PBYTemporary Tissue Marker2Product Code
- PDGElectrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.2Product Code
- PDWInternal Tissue Marker2Product Code
- PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis2Product Code
- PFPSilicone Hydrogel For Scar Management1Product Code
- PGZNon-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use2Product Code
- PJKTissue Adhesive For Internal Use3Product Code
- PKDLaceration Tray1Product Code
- PKELaparoscopic Cholecystectomy Kit1Product Code
- PKOTransparent Patch For Use In Treatment Of Tattoos2Product Code
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2Product Code
- PMCScalp Cooling System2Product Code
- PMXAbsorbable Collagen Hemostatic Agent With Thrombin3Product Code
- PNLMagnetic Surgical System2Product Code
- PODTemporary, Internal Use Hemostatic2Product Code
- PQIWound Retraction And Protection System2Product Code
- PSNLight Based Imaging2Product Code
- PTXSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt2Product Code
- PUIDrape, Surgical, Exempt2Product Code
- PXNBasic Set-Up Tray1Product Code
- PXOBone Marrow Biopsy Tray1Product Code
- PXPBreast Biopsy / Localization Tray1Product Code
- QRLMultiple Use Blood Lancet For Single Patient Use Only2Product Code
- PXQBurn Dressing Tray1Product Code
- PXRCement And Bone Removal Kit1Product Code
- PXSCholecystectomy Kit1Product Code
- PXUFluid Drainage Tray1Product Code
- PXVGeneral Purpose Instrument Tray1Product Code
- PXWHerniorraphy Kit1Product Code
- PXXIncision Tray1Product Code
- PXYIrrigation Kit (Wounds)1Product Code
- PXZLaparascopic Sphincterotomy Kit1Product Code
- PYALiver Biopsy Kit1Product Code
- PYBMinor Surgical Procedures Tray1Product Code
- PYCParacentesis Tray1Product Code
- PYDPelviscopy Kit1Product Code
- PYEStaple Removal Kit1Product Code
- PYFSterile Puncture Tray1Product Code
- PYGSuction Catheter Kit1Product Code
- PYHSurgical Retractor Kit1Product Code
- PYIThoracic Catheter Insertion Tray1Product Code
- PYJUlcer Wound Tray1Product Code
- PYKVenous Ulcer Kit1Product Code
- PYLWound Drainage Kit1Product Code
- PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers2Product Code
- PZQGeneral Laparoscopic Power Morcellation Containment System2Product Code
- QAIPowered Microneedle Device2Product Code
- QAUHemostatic Device For Endoscopic Gastrointestinal Use2Product Code
- QCRWound Autofluorescence Imaging Device2Product Code
- QCYLaser Absorbing Particles2Product Code
- QDFParathyroid Autofluorescence Detection Device2Product Code
- QDGParathyroid Autofluorescence Imaging Device2Product Code
- QRMMultiple Use Blood Lancet For Multiple Patient Use3Product Code
- QFCNegative Pressure Wound Therapy Device For Reduction Of Wound Complications2Product Code
- QHFEnergy Based Device For Treatment Of Tattoos2Product Code
- QJFAutofluorescence Imaging Adjunct Tool For Wounds2Product Code
- QKLLipoaspirate Washing System For Aesthetic Body Contouring2Product Code
- QNMMountable Electromechanical Surgical System For Transluminal Approaches2Product Code
- QPBSystem, Suction, Lipoplasty For Removal2Product Code
- QPXNegative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical2Product Code
- QPZContact Cooling For Skin Lesion Pain Relief2Product Code
- RABSunlamp Products (Pre-Standard)2Product Code
- REFSuntan Bed2Product Code
- REGSuntan Lamp2Product Code
- REHTabletop Sunlamp System2Product Code
- QUBSuction Lipoplasty System For Removal And Transfer2Product Code
- QVJLow Power Electrosurgical Devices For Skin Lesion Destruction2Product Code
- QZNMulti-Photon Imaging2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SmoothSkin BARE+
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K192010
- 510(k) Type
- Special
- Applicant
- CyDen Limited
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/24/2019
- Days to Decision
- 57 days
- Submission Type
- Statement