Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- EAQDetector, Ultraviolet2Product Code
- DYNMouthpiece, Saliva Ejector1Product Code
- EBRUnit, Suction Operatory1Product Code
- EBZActivator, Ultraviolet, For Polymerization2Product Code
- K253461Demi Pro2Cleared 510(K)
- K242386Bluemoon2Cleared 510(K)
- K243921LED Curing Lights (DB686 HALO)2Cleared 510(K)
- K250009LED Curing Light (C01-X, C02-X)2Cleared 510(K)
- K241238LOOP™ LED Curing Light System (CLK01)2Cleared 510(K)
- K223414Curing Light, Model: MaxCure 92Cleared 510(K)
- K233518BASE290 LED Curing Light2Cleared 510(K)
- K223507CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)2Cleared 510(K)
- K223142Coltolux Comfort LED Curing Light2Cleared 510(K)
- K220826LED Curing Light2Cleared 510(K)
- K221152CuringPen Dental Curing Light2Cleared 510(K)
- K221194LEDEX2Cleared 510(K)
- K220471VALO X, VALO X Accessory Lenses2Cleared 510(K)
- K210550VALO Grand Corded and Accessory Lenses2Cleared 510(K)
- K200775LOOP LED Curing Light System2Cleared 510(K)
- K200809D-LUX+2Cleared 510(K)
- K192233LED Curing Light2Cleared 510(K)
- K191221Cybird LED Curing Light2Cleared 510(K)
- K192009LED Curing Light2Cleared 510(K)
- K191865SmartLite Pro Modular LED Curing Light2Cleared 510(K)
- K190272Bluephase PowerCure2Cleared 510(K)
- K190627VALO Grand Corded2Cleared 510(K)
- K180065FUSION Plus Curing Light2Cleared 510(K)
- K181597Le'Pen2Cleared 510(K)
- K173157Dr's Light22Cleared 510(K)
- K173876Cybird LED Curing Light2Cleared 510(K)
- K161855LED Curing Light2Cleared 510(K)
- K172426Clear Blue Digi LED Curing Light2Cleared 510(K)
- K170529Delight, Delight ortho, B&Lite S2Cleared 510(K)
- K163064Demi Ultra2Cleared 510(K)
- K170101Valiant Curing Light2Cleared 510(K)
- K152192LED Curing Light2Cleared 510(K)
- K163613Bluephase Style 20i2Cleared 510(K)
- K163605LEDEX WL070+2Cleared 510(K)
- K153514Premium Plus C01/C02 LED Curing Light2Cleared 510(K)
- K160551VALO Grand2Cleared 510(K)
- K153078LED Curing Light GT-20002Cleared 510(K)
- K153018CELALUX 32Cleared 510(K)
- K150585Ascent 3D2Cleared 510(K)
- K152936Sirius Max Dental Diode Curing Light2Cleared 510(K)
- K150205LED Curing Light2Cleared 510(K)
- K140432HI-LIGHT, HI-LIGHT PLUS2Cleared 510(K)
- K133040LED CURING LIGHT2Cleared 510(K)
- K140281FLEXI-LUME LED SYSTEM2Cleared 510(K)
- K131906SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE2Cleared 510(K)
- K131042LEDEX2Cleared 510(K)
- K130163D-LUX2Cleared 510(K)
- K123468DEMI ULTRA2Cleared 510(K)
- K121093D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 30002Cleared 510(K)
- K110756BLUEPHASE STYLE2Cleared 510(K)
- K110582VALO CORDLESS2Cleared 510(K)
- K102621SOLSTICE2Cleared 510(K)
- K093751CL-DC20, CL-DC212Cleared 510(K)
- K092951STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS2Cleared 510(K)
- K091887LED CURING LIGHT, MODEL GT-15002Cleared 510(K)
- K091020BLUEPHASE 20I2Cleared 510(K)
- K083647VALO, MODEL 59192Cleared 510(K)
- K082408LEDEX, MODEL: WL-0702Cleared 510(K)
- K081287SAPPHIRE PLASMA ARC DENTAL CURING LIGHT2Cleared 510(K)
- K082971BONART ART-L5 LED CORDLESS CURING LIGHT2Cleared 510(K)
- K080025LED.L, LED.M, LED.G, LED.B2Cleared 510(K)
- K080035LED CURING LIGHT2Cleared 510(K)
- K073518FLASHLITE REBEL*2Cleared 510(K)
- K072807I LIGHT2Cleared 510(K)
- K072181MINI LED AUTOFOCUS2Cleared 510(K)
- K071908DOCTOR'S LIGHT LED DENTAL CURING LIGHT2Cleared 510(K)
- K071722DEEP BLUE2Cleared 510(K)
- K071251DEMI2Cleared 510(K)
- K063659EASY CURING PEN-STYLE LED CURING LIGHT2Cleared 510(K)
- K070373APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W2Cleared 510(K)
- K063529PENCURE, MODEL VL-72Cleared 510(K)
- K062289BONART ART-L3 LED CURING LIGHT2Cleared 510(K)
- K063116DEMETRON A.22Cleared 510(K)
- K063003AURORA2Cleared 510(K)
- K062735TUTU 7, MODEL IV-T222Cleared 510(K)
- K061658SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L2Cleared 510(K)
- K061695LED PROLUX 7702Cleared 510(K)
- K061395CALSET COMPOSITE HEATER2Cleared 510(K)
- K061341PALMLIGHT 10, MODEL 001-000302Cleared 510(K)
- K060646BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-8552Cleared 510(K)
- K052122BISCO LED2Cleared 510(K)
- K052349AVANTE LED CURING UNIT, MODEL N442Cleared 510(K)
- K052593FUSION CURING LIGHT2Cleared 510(K)
- K051782BLUEPHASE 16I2Cleared 510(K)
- K051780JETLITE 50002Cleared 510(K)
- K051571SKYLIGHT LED CURING LIGHT2Cleared 510(K)
- K051545L.E. DEMETRON II2Cleared 510(K)
- K051203BLUELEX2Cleared 510(K)
- K050059G-LIGHT2Cleared 510(K)
- K043530DVI CURING LIGHT2Cleared 510(K)
- K043302NOVA-PULSE2Cleared 510(K)
- K042888DEMETRON IDS CURING LIGHT2Cleared 510(K)
- K042196SAVEDENT BLUE2Cleared 510(K)
- K042703CYBIRD LED CURING LIGHT2Cleared 510(K)
- K042199TRANSLUX POWER BLUE2Cleared 510(K)
- K041372SMARTLITE PS PEN-STYLE LED CURING LIGHT2Cleared 510(K)
- K041303LED TURBO-PEN2Cleared 510(K)
- K040956HILUX LEDMAX 32Cleared 510(K)
- K040808MINI L.E.D. OEM MODULE2Cleared 510(K)
- K040614BLUEWAND LED DENTAL CURING WAND SYSTEM2Cleared 510(K)
- K040618LED TURBO2Cleared 510(K)
- K040551COLTOLUX LED CURING LIGHT2Cleared 510(K)
- K033697POWER LED2Cleared 510(K)
- K033795PLASMACURE BXE2Cleared 510(K)
- K033520BLUEPHASE2Cleared 510(K)
- K033201LA500 BLUE LIGHT2Cleared 510(K)
- K032099SWISS MASTER LIGHT2Cleared 510(K)
- K032465MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI2Cleared 510(K)
- K031615SLED CURING LIGHT SYSTEM2Cleared 510(K)
- K030811COOL CURE2Cleared 510(K)
- K030641CONTEC LIGHT2Cleared 510(K)
- K030568RADII2Cleared 510(K)
- K024374RMO PLASMA CURING LIGHT2Cleared 510(K)
- K023748FLASH-LITE II LED DENTAL CURING LIGHT2Cleared 510(K)
- K023721BONART ART-L2 LIGHT CURING UNIT2Cleared 510(K)
- K023652REMECURE MODEL CL 15E2Cleared 510(K)
- K023545ULTRA-LITE 200E LIGHT CURE UNIT2Cleared 510(K)
- K022862TRANSCURE, MODEL 29102Cleared 510(K)
- K022265LIGHT TIP2Cleared 510(K)
- K020057PALMLIGHT2Cleared 510(K)
- K022184FLASH-LITE LED DENTAL CURING LIGHT2Cleared 510(K)
- K021797L.E.DEMETRON2Cleared 510(K)
- K020884EXCELLITE LIGHT CURE UNIT2Cleared 510(K)
- K020877EXCELLITE TURBO LIGHT CURE UNIT2Cleared 510(K)
- K020874ULTRA-LITE 5 TURBO LIGHT CURE UNIT2Cleared 510(K)
- K021374TOESCO AQUA BLUE LED LIGHT CURING DEVICE2Cleared 510(K)
- K020267OPTILUX CURING LIGHTS2Cleared 510(K)
- K020091OPTILUX 5012Cleared 510(K)
- K014179DEMETRON LC2Cleared 510(K)
- K020171COOLBLU2 DENTAL RESIN CURING DEVICE2Cleared 510(K)
- K013500KAVO POLYLUX II2Cleared 510(K)
- K013277ASTRALIS 7, MODEL 5575452Cleared 510(K)
- K013275ASTRALIS 10, MODELS # 559588, 5618592Cleared 510(K)
- K012946SUNLITELED MODEL #28102Cleared 510(K)
- K012341TRANSLUX ENERGY2Cleared 510(K)
- K012134GC E-LIGHT2Cleared 510(K)
- K011154ELIPAR FREELIGHT2Cleared 510(K)
- K010133VERSALUX2Cleared 510(K)
- K003383PALMLIGHT2Cleared 510(K)
- K003683AVANTE CURELIGHT2Cleared 510(K)
- K002925COOLBLU CURING LIGHT2Cleared 510(K)
- K002991ZAP DUAL CURING LIGHT2Cleared 510(K)
- K002566LUMALITE CURE LIGHT, MODEL 21002Cleared 510(K)
- K001719Q-LUX PLASMA 100 LIGHT CURE UNIT2Cleared 510(K)
- K000078JETLITE 40002Cleared 510(K)
- K000426VIP- VARIABLE INTENSITY POLYMERIZER2Cleared 510(K)
- K000393NOVA CORDLESS CURING LIGHT2Cleared 510(K)
- K994048PORTABLE LIGHT CURING UNIT2Cleared 510(K)
- K994028FLIPO XENON CURING LIGHT2Cleared 510(K)
- K993223RAPICURE 200 (CURING AND WHITENING LIGHT)2Cleared 510(K)
- K992728SPRING POWERLITE 20002Cleared 510(K)
- K992357EASY-CURE (CURING AND WHITENING LIGHT)2Cleared 510(K)
- K992236LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA2Cleared 510(K)
- K991865Q-LITE 75 LIGHT CURE UNIT2Cleared 510(K)
- K991863CUTE-LITE I LIGHT CURE UNIT2Cleared 510(K)
- K991138LYSTA LC CURING LIGHT, MODEL LC 2500C/BA2Cleared 510(K)
- K984247ELIPAR TRILIGHT2Cleared 510(K)
- K982615AIRDENT RADIANCE CURING LIGHT2Cleared 510(K)
- K974369APOLLO 95002Cleared 510(K)
- K9723553M AURORA SYSTEM2Cleared 510(K)
- K972006ACTA OEM MODULE2Cleared 510(K)
- K970506HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT2Cleared 510(K)
- K964524ILT ARGON HP2Cleared 510(K)
- K963110JETLITE2Cleared 510(K)
- K961735ACTA2Cleared 510(K)
- K960364CU-200 LIGHT CURE UNIT2Cleared 510(K)
- K960351Q-LUX LIGHT CURE UNIT2Cleared 510(K)
- K953898ACL-5500 PRECISION CURING UNIT (PCU)2Cleared 510(K)
- K955763OPTILUX 4002Cleared 510(K)
- K955759LITEX 6802Cleared 510(K)
- K954061POLY-LITE MODEL 10002Cleared 510(K)
- K952423CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A7156762Cleared 510(K)
- K951465SUNLITE 12752Cleared 510(K)
- K950106COLTOLUX LIGHT METER2Cleared 510(K)
- K945698COLTOLUX 3, COLTOLUX 42Cleared 510(K)
- K951425SPECTRUM CURING LIGHT POLYMERIZATION UNIT2Cleared 510(K)
- K942199CU-100R LIGHT CURE UNIT, DOCUMENT NO. A7156762Cleared 510(K)
- K942198CU-80 LIGHT CURE UNIT, DOCUMENT NO. A7156762Cleared 510(K)
- K9347463M CURING LIGHT XL15002Cleared 510(K)
- K930086ORTHOLUX XT2Cleared 510(K)
- K9248123M CURING LIGHT XL 30002Cleared 510(K)
- K912994COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE2Cleared 510(K)
- K913980HELIOLUX2Cleared 510(K)
- K910068SPECTRAMAT2Cleared 510(K)
- K905543LARES APOLLO CS/CP/C2Cleared 510(K)
- K901908HELIOLUX VISIBLE CURING LIGHT2Cleared 510(K)
- K900135CU-75 VISIBLE LIGHT-CURING UNIT2Cleared 510(K)
- K895085WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT2Cleared 510(K)
- K892517TULUX-FILTER2Cleared 510(K)
- K892456KULZER TRANSLUX EC2Cleared 510(K)
- K884222CURING LIGHT COVER2Cleared 510(K)
- K882145PHOTO-CURING LIGHT2Cleared 510(K)
- K880392ORTHOLUX VISIBLE LIGHT CURING UNIT2Cleared 510(K)
- K854696OP II VISIBLE LIGHT CURING SYSTEM2Cleared 510(K)
- K851915CURING LIGHT2Cleared 510(K)
- K844351OPTI-LITE2Cleared 510(K)
- K844325COE-LITE POLYMERIZATION UNIT2Cleared 510(K)
- K843823TRANSLUX CL2Cleared 510(K)
- K832320PRISMA III2Cleared 510(K)
- K822654CURING LIGHT2Cleared 510(K)
- K822642OPTILUX & VISILUX DENTAL PHOTO LAMP2Cleared 510(K)
- K820693MIDWEST LIGHT WAND2Cleared 510(K)
- K811668KULZER TRANSLUX VISIBLE LIGHT CURING2Cleared 510(K)
- K803209ELIPAR LIGHT SOURCE2Cleared 510(K)
- K801588CAULK PRISMA-LITE2Cleared 510(K)
- K780898INSTANT CURE-12Cleared 510(K)
- K780518ULTRANOVAR, DENTAL U.V. CURING LAMP2Cleared 510(K)
- K772278FOTOFILL ACTIVATOR LIGHT2Cleared 510(K)
- K771889UNIOLITE2Cleared 510(K)
- K771077ULTRAVIOLET RAD-EMITTING LAMP2Cleared 510(K)
- K770215ACTIVATOR LIGHT2Cleared 510(K)
- K770599NUVA-LITE II PHOTO-CURE UNIT2Cleared 510(K)
- K770113ESTILUX UV SYSTEM2Cleared 510(K)
- ECCSterilizer, Glass Bead3Product Code
- ECGSterilizer, Boiling Water1Product Code
- EEAPlate, Base, Shellac1Product Code
- EEFClamp, Rubber Dam1Product Code
- EEGHeat Source For Bleaching Teeth1Product Code
- EEJGuard, Disk1Product Code
- EFCWarmer, Anesthetic Tube1Product Code
- EFHPaper, Articulation1Product Code
- EFNCotton, Roll1Product Code
- EFSUnit, Oral Irrigation1Product Code
- EFWToothbrush, Manual1Product Code
- EFXProtector, Silicate1Product Code
- EGDWax, Dental, Intraoral1Product Code
- EHJDisk, Abrasive1Product Code
- EHKCup, Prophylaxis1Product Code
- EHLPoint, Abrasive1Product Code
- EHMStrip, Polishing Agent1Product Code
- EHYTray, Impression, Preformed1Product Code
- EHZEvacuator, Oral Cavity1Product Code
- EIAUnit, Operative Dental1Product Code
- EIEDam, Rubber1Product Code
- EIHPowder, Porcelain2Product Code
- EJEFrame, Rubber Dam1Product Code
- EJGForceps, Rubber Dam Clamp1Product Code
- EJISyringe, Cartridge2Product Code
- EJQWheel, Polishing Agent1Product Code
- EJRAgent, Polishing, Abrasive, Oral Cavity1Product Code
- JEQToothbrush, Powered1Product Code
- JESFloss, Dental1Product Code
- JETPick, Massaging1Product Code
- JEWTip, Rubber, Oral Hygiene1Product Code
- KCQTube Impression And Matrix1Product Code
- KHRAbsorber, Saliva, Paper1Product Code
- KLCChair, Dental, With Operative Unit1Product Code
- KMTTray, Fluoride, Disposable1Product Code
- KOJAirbrush2Product Code
- KOKSterilizer, Endodontic Dry Heat3Product Code
- LCNScraper, Tongue1Product Code
- MAUEraser, Dental Stain1Product Code
- MCFUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile1Product Code
- MMDToothbrush, Ionic, Battery-Powered1Product Code
- NOBUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile1Product Code
- NRDUnit, Operative Dental, Accessories1Product Code
- NRUChair, Dental, Without Operative Unit1Product Code
- NXVDiagnostic Light, Soft Tissue Detector2Product Code
- NXZDental Hygiene Kit1Product Code
- PIPProphy Powder, Airbrush Accessory2Product Code
- OFXGeneral Purpose Dental Tray1Product Code
- PFLIntraoral, Dental Foam Protector1Product Code
- QGOComposite Resin Warmer1Product Code
- QIAPowered Tongue Scraper1Product Code
- QJCPlaque Disclosing Agent1Product Code
- QMJPowered Radiofrequency Toothbrush2Product Code
- QNFLaser Activator For Polymerization2Product Code
- QYJDental Waterline Treatment Cartridge1Product Code
- 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
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Le'Pen
- Page Type
- Cleared 510(K)
- 510(k) Number
- K181597
- 510(k) Type
- Traditional
- Applicant
- KMIHH Ltd
- Country
- Israel
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/1/2019
- Days to Decision
- 287 days
- Submission Type
- Summary