FDA Product Code
FDA Product Code ILY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5500
510(k) Clearances — 229 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K082707 | MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER | Medx Electronics, Inc. | 2008-10-01 | Traditional | PDF ↗ |
| K080102 | TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM | Escada International, Inc. | 2008-08-20 | Special | PDF ↗ |
| K073352 | WEBERNEEDLE BASIC LASER | Weber Medical GmbH | 2008-08-11 | Traditional | PDF ↗ |
| K080465 | WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES | Ws Far IR Medical Technology Co., Ltd. | 2008-07-18 | Traditional | PDF ↗ |
| K080689 | SPECTRA THERAPY SYSTEM A1000 LASER DEVICE | Premier Dynamics, Inc. | 2008-07-09 | Traditional | PDF ↗ |
| K072399 | DEL SOL RED LIGHT THERAPY SYSTEM | Edge Systems, Inc. | 2008-05-23 | Traditional | PDF ↗ |
| K080084 | CELL GEN LASER, MODEL CG-4000 | Cell Gen Therapeutics, LLC | 2008-04-21 | Traditional | PDF ↗ |
| K080318 | ALMA LASER NIR MODULE | Alma Lasers , Ltd. | 2008-03-07 | Traditional | PDF ↗ |
| K070690 | THE LIFE VESSEL | Cottonwood Vessel Corporation | 2007-11-16 | Traditional | PDF ↗ |
| K072048 | LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE | Lynton Lasers Limited | 2007-11-16 | Traditional | PDF ↗ |
| K071445 | TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS | Escada International, Inc. | 2007-10-29 | Traditional | PDF ↗ |
| K070338 | RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS | Rainbow Communications, Inc. | 2007-08-28 | Traditional | PDF ↗ |
| K070516 | POWERLASER | Powermedic Aps | 2007-07-02 | Traditional | PDF ↗ |
| K070974 | LIGHT RELIEF, MODEL LR150, LR200 | Light Relief, LLC | 2007-05-24 | Special | PDF ↗ |
| K070024 | THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE | Thor International | 2007-05-16 | Traditional | PDF ↗ |
| K063745 | MEDILASER, MODEL 1000 | Laser Thera, LLC | 2007-04-23 | Traditional | PDF ↗ |
| K063568 | HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL | Suzhou Medical Appliance Factory | 2007-03-22 | Traditional | PDF ↗ |
| K070400 | LC THERAPY, MODEL LCT-1000 | Litecure, LLC | 2007-02-28 | Traditional | PDF ↗ |
| K062635 | MODEL 2200 | Clarimedex, Inc. | 2006-12-19 | Traditional | PDF ↗ |
| K060792 | ILLUMIMED | Photoactif, LLC | 2006-12-01 | Traditional | PDF ↗ |
| K061614 | TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS | Escada International, Inc. | 2006-10-06 | Special | PDF ↗ |
| K060153 | ACUMED LASER, MODEL 1000 | Laser Thera, LLC | 2006-09-29 | Traditional | PDF ↗ |
| K052492 | AIRNERGY+STREAM | Natural Energy Solutions AG | 2006-09-05 | Traditional | PDF ↗ |
| K060191 | ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT | Accelerated Care Plus Corp. | 2006-07-12 | Traditional | PDF ↗ |
| K061080 | IR PRO 250 | Lhasa Oms, Inc. | 2006-06-14 | Traditional | PDF ↗ |
| K060134 | APOLLO IR HEAT LAMP SYSTEM | Apollo Physical Therapy Products International | 2006-03-21 | Traditional | PDF ↗ |
| K051875 | BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS | Meditech International, Inc. | 2006-03-13 | Traditional | PDF ↗ |
| K053376 | CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810 | Chung Cheng Electric Heating Co., Ltd. | 2006-02-16 | Traditional | PDF ↗ |
| K051961 | WWMED, MODEL 401 | Wong Way Corporation | 2006-02-10 | Traditional | PDF ↗ |
| K053473 | MAESTRO MDTL LASER SYSTEM | Advanced Medical Technologies, Inc. | 2006-02-03 | Traditional | PDF ↗ |
| K052307 | BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM | Beamline Corporation | 2005-12-16 | Traditional | PDF ↗ |
| K053201 | CURAE'LASE CL1000 IR LASER SYSTEM | Curae'Lase, Inc. | 2005-12-09 | Traditional | PDF ↗ |
| K052814 | LUMINA 1600, 3300 AND 6600 SYSTEMS | Usa Laser Biotech, Inc. | 2005-11-30 | Traditional | PDF ↗ |
| K052647 | CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55. | American Spine Center, Ltd. | 2005-11-09 | Traditional | PDF ↗ |
| K051548 | IRRADIA MID - LASER (S3) | Irradia AB | 2005-10-24 | Traditional | PDF ↗ |
| K051680 | DYNATRON DX2 TRACTION UNIT | Dynatronics Corp. | 2005-10-11 | Traditional | PDF ↗ |
| K052063 | HUANQIU HEATING LAMP | A & A Medical Supplies, Inc. | 2005-09-30 | Traditional | PDF ↗ |
| K051537 | HILT FAMILY LASER: HILT I, HILT II, HILT III | Cynosure, Inc. | 2005-09-26 | Traditional | PDF ↗ |
| K051922 | ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 | Cynosure, Inc. | 2005-09-14 | Traditional | PDF ↗ |
| K051816 | LUMIWAVE 1X4 INFRARED THERAPY DEVICE | Biocare Systems, Inc. | 2005-08-26 | Special | PDF ↗ |
| K051681 | DERMILLUME RED, MODEL HR1000 | Care Electronics, Inc. | 2005-07-27 | Traditional | PDF ↗ |
| K051261 | DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE | Dynatronics Corp. | 2005-07-25 | Traditional | PDF ↗ |
| K043055 | TERRAQUANT MQ2000 LASER THERAPY DEVICE | Escada International, Inc. | 2005-07-25 | Traditional | PDF ↗ |
| K050370 | PALOMAR LUXIR HANDPIECE | Palomar Medical Technologies, Inc. | 2005-06-15 | Traditional | PDF ↗ |
| K043306 | SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR | Skylark Device & Systems Co., Ltd. | 2005-06-06 | Traditional | PDF ↗ |
| K043558 | XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A | Chongqing Xinfeng Medical Instruments Co., Ltd. | 2005-06-06 | Traditional | PDF ↗ |
| K051046 | PAINACEA MODEL XR8 INFRARED HEAT LAMP | Atlantis Luminescent Products, LLC | 2005-05-10 | Traditional | PDF ↗ |
| K043586 | LASER SYS*STIM 540, MODEL ME 540 | Mettler Electronics Corp. | 2005-05-06 | Abbreviated | PDF ↗ |
| K050022 | MEDX HOME | Medx Electronics, Inc. | 2005-05-05 | Traditional | PDF ↗ |
| K050070 | K-LASER, MODELS 3,4,4D,6D | Eltech S.R.L | 2005-03-25 | Traditional | PDF ↗ |
| K043317 | OMNILUX PLUS | Photo Therapeutics Limited | 2005-03-15 | Traditional | PDF ↗ |
| K042813 | BIOBEAM NARROW BAND LIGHT THERAPY DEVICES | Life Without Pain, LLC | 2005-02-25 | Traditional | PDF ↗ |
| K041885 | BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS | Meditech International, Inc. | 2005-02-24 | Traditional | PDF ↗ |
| K041679 | COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT | Onyx Medical, Inc. | 2004-12-16 | Abbreviated | PDF ↗ |
| K041364 | ML830 LASER SYSTEM | Microlight Corporation of America | 2004-12-13 | Traditional | PDF ↗ |
| K042532 | BIOCARE SYSTEMS PREMIR 818 | Biocare Systems, Inc. | 2004-12-13 | Traditional | PDF ↗ |
| K030275 | MB SYSTEM, BIOENERGY LIGHT THERAPY | Amest Corp. | 2004-11-29 | Traditional | PDF ↗ |
| K042256 | IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE | Usa Laser Biotech, Inc. | 2004-11-17 | Traditional | PDF ↗ |
| K042165 | CUTERA TABLETOP AESTHETIC PRODUCT | Cutera, Inc. | 2004-10-18 | Traditional | PDF ↗ |
| K040662 | VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS | Chattanooga Group | 2004-09-08 | Traditional | PDF ↗ |
| K040729 | SOLARIS D890 THERAPY PROBE | Dynatronics Corp. | 2004-06-02 | Traditional | PDF ↗ |
| K040664 | OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004 | Omnilight, Inc. | 2004-05-28 | Traditional | PDF ↗ |
| K040679 | RICH-MAR AUTOPRISM INFRARED LAMP | Rich-Mar Corp. | 2004-05-07 | Traditional | PDF ↗ |
| K033986 | MLT-1000 IR LASER SYSTEM | Medical Laser Therapeutics LP | 2004-03-29 | Traditional | PDF ↗ |
| K033923 | TH0R DDII IR LAMP SYSTEM | Thor Intl. | 2004-03-17 | Traditional | PDF ↗ |
| K033555 | KENKOWAVE INFRARED PAIN TREATMENT SYSTEM | Kaylight Corporation | 2004-03-02 | Traditional | PDF ↗ |
| K033768 | ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE | Altus Medical, Inc. | 2004-02-17 | Traditional | PDF ↗ |
| K031612 | ALT LASER, MODEL VTR 75 | Avicenna Laser Technology, Inc. | 2003-12-11 | Traditional | PDF ↗ |
| K024027 | LIGHTWAVE INFRARED LAMPS LW10D AND LW30D | Skytech Enterprises, Inc. | 2003-12-03 | Traditional | PDF ↗ |
| K032379 | QUASAR, MODEL MD21 | Quantum Skincare, Inc. | 2003-11-20 | Traditional | PDF ↗ |
| K032787 | NEUROLASE, MODELS 150V, 150C, 1064 | Spectrum Laser & Technologies | 2003-11-20 | Traditional | PDF ↗ |
| K033035 | TLC MODELS ULK-H AND ULT-H INFRARED LAMPS | Tlc Marketing, Inc. | 2003-11-20 | Traditional | PDF ↗ |
| K024361 | EM PROBE, EM PAD | Em Probe, Inc. | 2003-10-09 | Traditional | PDF ↗ |
| K032231 | MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER | Medx Electronics, Inc. | 2003-10-03 | Traditional | PDF ↗ |
| K032229 | QUANTUM WARP 10 LIGHT DELIVERY SYSTEM | Quantum Devices, Inc. | 2003-09-12 | Traditional | PDF ↗ |
| K024179 | PALOMAR LIGHTCUBE | Palomar Medical Products, Inc. | 2003-06-04 | Traditional | PDF ↗ |
| K023621 | BIOFLEX PROFESSIONAL THERAPY SYSTEM | Meditech International, Inc. | 2003-04-10 | Traditional | PDF ↗ |
| K022609 | SURGICAL PATIENT WARMER, MODEL PW820 JHU | Fisher & Paykel Healthcare, Ltd. | 2003-03-06 | Traditional | PDF ↗ |
| K022888 | ACUBEAM, SUPER NOVA, DIO | Light Force Therapy, Inc. | 2002-12-11 | Traditional | PDF ↗ |
| K020851 | TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D | C&H International | 2002-09-23 | Traditional | PDF ↗ |
| K020464 | SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 | Rolor Electronics Corp. | 2002-09-17 | Traditional | PDF ↗ |
| K020462 | SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018 | Rolor Electronics Corp. | 2002-09-16 | Traditional | PDF ↗ |
| K013197 | WS-501 HEAT LAMP | Lhasa Medical, Inc. | 2002-08-29 | Traditional | PDF ↗ |
| K021956 | MHS MED LIGHT 1000 | Micro Health Systems, Inc. | 2002-08-13 | Traditional | PDF ↗ |
| K020017 | MEDX 1000 SERIES | Medx Electronics, Inc. | 2002-07-12 | Traditional | PDF ↗ |
| K014208 | SSIR SYSTEM | Russian-American Technology Associates, Inc. | 2002-07-02 | Traditional | PDF ↗ |
| K011355 | BIOLIGHT PCD | Biolight International AB | 2002-01-17 | Traditional | PDF ↗ |
| K012508 | MU PHOTONICS PAIN THERAPIST | Nu Photonics, Inc. | 2001-10-09 | Traditional | PDF ↗ |
| K003538 | TDP CQ-27 HEAT LAMP | Lhasa Medical, Inc. | 2001-06-04 | Traditional | PDF ↗ |
| K001179 | SUPER NOVA, ACUBEAM | Light Force Therapy, Inc. | 2000-10-27 | Traditional | PDF ↗ |
| K001056 | OLYMPIC WARM-UP | Olympic Medical Corp. | 2000-09-29 | Traditional | PDF ↗ |
| K993684 | SPINAL PAD | Bioscan, Inc. | 2000-07-19 | Traditional | PDF ↗ |
| K993685 | BIOPACK | Bioscan, Inc. | 2000-07-18 | Traditional | PDF ↗ |
| K993686 | LIGHT PATCH | Bioscan, Inc. | 2000-07-18 | Traditional | PDF ↗ |
| K993123 | QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B | United Pacific Co., Ltd. | 1999-12-17 | Traditional | PDF ↗ |
| K990233 | ST-302 INFRAREX | Skylark Device Co., Ltd. | 1999-10-27 | Traditional | PDF ↗ |
| K991503 | SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36 | United Pacific Co., Ltd. | 1999-07-28 | Traditional | PDF ↗ |
| K982636 | PATIENT WARMER- MODEL PW810 | Fisher & Paykel Healthcare, Ltd. | 1998-10-26 | Traditional | PDF ↗ |
| K982546 | PHASER-2000 | Diomedics, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K974468 | PHOTONIC STIMULATOR | Bales Scientific, Inc. | 1998-06-22 | Traditional | PDF ↗ |
Product code ILY · Class II · Physical Medicine. Data: openFDA.