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GEX

2,872 FDA 510(k) clearances · Product code

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RecordFirmDateBuilder
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (K884459)Luxar Corp.1988-12-19+ Add
CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. (K883488)Heraeus Lasersonics, Inc.1988-12-19+ Add
SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP (K884994)Sharplan Lasers, Inc.1988-12-15+ Add
STERILE DISPOSABLE ENDOCULAR PROBE (K884456)Biophysic Medical, Inc.1988-12-09+ Add
HEXASCAN HANDPIECE FOR ARGON/DYE LASER (K884431)California Laboratories, Inc.1988-12-02+ Add
KTP/532 SURGICAL LASER (K884029)Laserscope1988-11-25+ Add
CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. (K883738)Directed Energy, Inc.1988-11-15+ Add
METALASER VASCULASE (K883541)Metatech Corp.1988-11-04+ Add
MEDITEC QL-15 ND:YAG LASER (K884060)Storz Ophthalmics, Inc.1988-11-04+ Add
COHERENT EXCELITE CO2 AIR FIBER (K884204)Coherent Medical Lasers1988-11-03+ Add
CO2 SURGICAL LASER SYSTEM MODEL #IR105 (K882951)Niic U.S.A., Inc.1988-11-02+ Add
CO2 SURGICAL LASER SYSTEM MODEL #IR106 (K882952)Niic U.S.A., Inc.1988-11-02+ Add
MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS (K884311)Surgilase, Inc.1988-10-27+ Add
MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS (K884313)Surgilase, Inc.1988-10-27+ Add
CODMAN NEUROLASE LASER SYSTEM (K883642)I.L. Med, Inc.1988-10-20+ Add
SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80 (K884092)Surgilase, Inc.1988-10-13+ Add
4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02 (K883089)Heraeus Lasersonics, Inc.1988-09-28+ Add
SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS (K883563)Sharplan Lasers, Inc.1988-09-27+ Add
MODEL AU-1 ACCESSORY UNIT (K882926)Directed Energy, Inc.1988-09-09+ Add
KTP/YAG(TM) SURGICAL LASER (K882734)Laserscope1988-09-09+ Add
HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900 (K882365)Heraeus Lasersonics, Inc.1988-09-02+ Add
L.P.I. LASER DELIVERY SYSTEM (K882738)Laser Photonics, Inc.1988-08-30+ Add
LQ1106 OPHTHALMIC YAG LASER (K882772)Keeler Instruments, Inc.1988-08-26+ Add
LASER MIXTURE (K882942)Swisco, Inc.1988-08-23+ Add
SLT CONTACT LASER SYSTEM (K882212)Surgical Laser Technologies, Inc.1988-08-17+ Add
MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES (K882208)Linde Div. Union Carbide Corp.1988-08-03+ Add
THREE-COMPONENT MEDICAL LASER GAS MIXTURES (K882516)Matheson Gas Products, Inc.1988-08-03+ Add
MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM (K880816)Niic U.S.A., Inc.1988-08-01+ Add
MODEL 20 KY KRYPTON YELLOW LASER (K881940)Hgm Medical Laser Systems, Inc.1988-07-20+ Add
SL-100 ND:YAG LASER FOR GYNECOLOGY USE (K871512)Medical Energy, Inc.1988-07-08+ Add
4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER (K881619)Heraeus Lasersonics, Inc.1988-07-08+ Add
SPTL-1 PULSED DYE LASER (K882243)Candela Laser Corp.1988-07-05+ Add
KTP/532(TM) SURGICAL LASER (K881788)Laserscope1988-06-27+ Add
COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR (K882160)Coherent Medical Lasers1988-06-22+ Add
FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM (K880061)Abbott Laboratories1988-06-20+ Add
SHARPLAN MEDILAS 4060 N (K882037)Sharplan Lasers, Inc.1988-06-20+ Add
MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT (K881583)Laser Engineering, Inc.1988-06-03+ Add
MODEL MD-45 CO2 LASER FOR ENT APPLICATIONS (K881586)Laser Engineering, Inc.1988-06-03+ Add
MODEL MD-25 LASER FOR SURGICAL USE (K881588)Laser Engineering, Inc.1988-06-03+ Add
MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE (K881584)Laser Engineering, Inc.1988-06-03+ Add
MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY (K881580)Laser Engineering, Inc.1988-06-03+ Add
MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE (K881581)Laser Engineering, Inc.1988-06-03+ Add
SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI. (K881952)Sharplan Lasers, Inc.1988-06-03+ Add
MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE (K881585)Laser Engineering, Inc.1988-06-03+ Add
MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE (K881582)Laser Engineering, Inc.1988-06-03+ Add
MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS (K881587)Laser Engineering, Inc.1988-06-03+ Add
SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU (K881953)Sharplan Lasers, Inc.1988-06-03+ Add
MODIFIED SHARPLAN MODEL 1020 CO2 LASER (K882180)Sharplan Lasers, Inc.1988-06-02+ Add
SHARPLAN ND:YAG SURGICAL HAND APPLICATORS (K881870)Sharplan Lasers, Inc.1988-05-24+ Add
LASER MICROMANIPULATOR (K881824)Pfizer Laser Systems1988-05-24+ Add
SHARPLAN 719Y MICROSLAD(TM) (K881887)Sharplan Lasers, Inc.1988-05-13+ Add
MODIFIED MODEL 2100 ND:YAG LASER (K881848)Sharplan Lasers, Inc.1988-05-11+ Add
MODEL PC ARGON LASER (K880908)Hgm, Inc.1988-05-03+ Add
ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU (K880809)Cooper Lasersonics, Inc.1988-04-18+ Add
ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU (K880807)Cooper Lasersonics, Inc.1988-04-18+ Add
ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU (K880808)Cooper Lasersonics, Inc.1988-04-18+ Add
CHRYS(TM) MODEL MED-MAX (K875338)California Laboratories, Inc.1988-04-13+ Add
COHERENT XA-40 CO2 SURGICAL LASER (K880603)Coherent Medical Group1988-03-11+ Add
MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. (K880216)Directed Energy, Inc.1988-03-04+ Add
INFRAGUIDE(TM) (K875115)Cooper Lasersonics, Inc.1988-02-26+ Add
SUN MEDICAL SMOKE EVACUATOR SYSTEM (K874948)Sun Medical, Inc.1988-02-18+ Add
MODEL 5202 MICROMANIPULATOR (K874811)Coherent Medical Group1988-02-05+ Add
COHERENT XA-30/SP CO2 SURGICAL LASER (K874648)Coherent Medical Group1988-02-04+ Add
MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY (K873790)Cooper Lasersonics, Inc.1988-01-22+ Add
MODEL 5050 SURGILASER FOR NEUROSURGERY USE (K871933)Lasermatic, Inc.1988-01-22+ Add
ULTRASPOT MICROMANIPULATOR (K873443)Cooper Lasersonics, Inc.1988-01-06+ Add
SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER (K873760)Coherent Medical Group1987-11-27+ Add
MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2 (K873246)Coherent Medical Group1987-11-10+ Add
LIGHT-SPOT FIBEROPTIC LASER HANDPIECE (K873664)Laserguide1987-11-06+ Add
LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE (K873571)Laserguide1987-11-06+ Add
COHERENT XA-30 CO2 SURGICAL LASER (K873963)Coherent Medical Group1987-10-19+ Add
ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER (K873773)Hgm, Inc.1987-10-13+ Add
CODMAN NEUROLASE LASER SYSTEM (K872179)Codman & Shurtleff, Inc.1987-10-07+ Add
MDS-90 ARGON DYE LASER FOR DERMATOLOGY (K872578)Meditec of America1987-10-01+ Add
MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY (K872711)Directed Energy, Inc.1987-09-28+ Add
ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR (K872589)Class, Inc.1987-09-11+ Add
LPM-1 (LASER POWER METER) (K871619)Bio-Tek Instruments, Inc.1987-07-28+ Add
LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER (K871206)Phase-R Corp.1987-07-22+ Add
LASE SYSTEM II (K871334)Lase, Inc.1987-06-01+ Add
MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT (K870970)Directed Energy, Inc.1987-05-26+ Add
MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE (K870837)Directed Energy, Inc.1987-05-26+ Add
MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT (K870971)Directed Energy, Inc.1987-05-26+ Add
MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE (K870838)Directed Energy, Inc.1987-05-26+ Add
MODEL 5000 MICROMANIPULATOR MICRO CO2 LASER SYSTEM (K870161)Coherent Medical Group1987-04-14+ Add
0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE (K870517)Coherent Medical Group1987-04-10+ Add
ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU (K864887)Bio Quantum Technologies, Inc.1987-04-10+ Add
MODEL LS 840, CO2 LASER (K864563)Cooper Lasersonics, Inc.1987-04-09+ Add
MODEL LS 860, CO2 LASER (K864562)Cooper Lasersonics, Inc.1987-04-09+ Add
OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO (K862514)Laserscope1987-02-04+ Add
SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG (K863086)Cooper Lasersonics, Inc.1986-12-04+ Add
CANDELA MODEL SPT-1, PULSED DYE LASER (K861179)Candela Corp.1986-11-20+ Add
LASER SURGICAL ROD (K862815)Lifestream Int'L, Inc.1986-11-17+ Add
MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND (K861044)Sharplan Industries, Inc.1986-10-28+ Add
ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY (K863183)Cooper Lasersonics, Inc.1986-10-24+ Add
MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE (K862863)Directed Energy, Inc.1986-10-24+ Add
MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG (K862408)Directed Energy, Inc.1986-10-24+ Add
MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY (K862864)Directed Energy, Inc.1986-10-24+ Add
XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 (K861688)Xanar, Inc.1986-10-03+ Add
MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY (K862422)Directed Energy, Inc.1986-10-02+ Add
MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) (K860831)Cooper Lasersonics, Inc.1986-10-02+ Add
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