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GEX

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

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RecordFirmDateBuilder
URANUS, COMFORTOUCH LASER SYSTEM (K001031)Laser Max Medical Technologies Corp.2000-06-29+ Add
OPUS 10 DENTAL DIODE LASER (K000990)Opusdent , Ltd.2000-06-23+ Add
DORNIER MEDILAS D SKINPULSE (K000072)Dornier Surgical Products, Inc.2000-06-12+ Add
LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) (K994116)Aesculap-Meditec North America2000-06-01+ Add
CANDELA GENTLELASE GL DERMATOLOGICAL LASER (K994260)Candela Corp.2000-05-26+ Add
DORNIER MEDILAS H (K001243)Dornier Surgical Products, Inc.2000-05-24+ Add
PALOMAR SLP 2000 (K994225)Palomar Medical Technologies, Inc.2000-05-18+ Add
UMECO OPTIMA MULTILINE LASER SYSTEM (K000693)Medical Laser Solutions, LLC2000-05-16+ Add
MEDART 520 COOLING SYSTEM (K000503)Medart Corp.2000-05-15+ Add
UNI-LASER 430 (K993815)Medart Corp.2000-05-11+ Add
SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 (K001263)E S C Sharplan2000-05-05+ Add
KAVO K.E.Y. LASER 1242 (K000805)Kavo America2000-05-04+ Add
A100 AESTHETIC DIODE LASER (K000982)Diomed, Inc.2000-05-01+ Add
LORAD LT-100 LASER TREATMENT SYSTEM (K992597)Focus Medical, LLC2000-04-24+ Add
UM-L25 (K000222)Union Medical Engeneering Co., Ltd.2000-04-19+ Add
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES (K000106)Fotona D.D.2000-04-18+ Add
E3 MICROPROB SERIES OF LASERS AND ACCESSORIES (K000192)Martin Uram, MD2000-04-10+ Add
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER (K000498)Lumenis, Inc.2000-03-13+ Add
CYNOSURE PHOTOGENICA VLS-STAR (K000490)Cynosure, Inc.2000-03-13+ Add
ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) (K990718)Laserscope2000-03-08+ Add
ACME MEDICAL AESTHETIC ND:YAG LASER (K991798)Altus Medical2000-03-06+ Add
ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT (K994014)Esc Medical Systems , Ltd.2000-02-24+ Add
SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C (K993834)Cardiofocus, Inc.2000-02-04+ Add
CERALAS D10 810NM DIODE LASER (K993828)Ceram Optec, Inc.2000-02-01+ Add
CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 (K993911)Ceram Optec, Inc.2000-02-01+ Add
EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000 (K992914)Acculase, Inc.2000-01-27+ Add
EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM (K991935)Esc Medical Systems , Ltd.2000-01-27+ Add
CANDELA SCLERO LONG PULSE DYE LASER (K993671)Candela Corp.2000-01-24+ Add
MODEL 1000 HOLMIUM LASER SYSTEM (K994273)New Star Lasers, Inc.2000-01-20+ Add
CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL (K994427)Cynosure, Inc.2000-01-18+ Add
CYNOSURE PHOTOGENICA SPIR (K994437)Cynosure, Inc.2000-01-18+ Add
LITESABER 2000 (K993942)Laser Dental Innovations2000-01-18+ Add
DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM) (K992482)Radiancy, Ltd.1999-12-27+ Add
SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY (K993209)Thermolase Corp.1999-12-23+ Add
INNOVAQUARTZ GENERAL SHAPE LASER FIBER (K994010)Innovaquartz1999-12-17+ Add
INTRALASE 600C LASER KERATOME (K993153)Intra Lase Corp.1999-12-17+ Add
IRIDERM, MODEL APEX 800 (K992298)Iridex Corp1999-12-09+ Add
AURORA SL (K993285)Premier Laser Systems, Inc.1999-11-18+ Add
OPTILITE IX LASER SURGERY ACCESSORIES (K992866)Convergent Laser Technologies1999-11-18+ Add
PHACOLASE ER: YAG LASER (K991993)Aesculap-Meditec GmbH1999-11-17+ Add
LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL (K992824)Ellex Medical Pty, Ltd.1999-11-17+ Add
DORNIER SCANNER HANDPIECE (K993146)Dornier Surgical Products, Inc.1999-11-08+ Add
OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A (K992574)Trimedyne, Inc.1999-10-29+ Add
MCL 29 DERMABLATE ER:YAG LASER SYSTEM (K992707)Aesculap-Meditec North America1999-10-19+ Add
CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 (K993002)Ceram Optec, Inc.1999-10-14+ Add
TECHNOSANAT KRYO TSK 2005 (K992536)Technosanat Innovative Medizintechnik GmbH1999-10-08+ Add
AURORA HL (K992374)Premier Laser Systems, Inc.1999-09-22+ Add
CYNOSURE ACCOLADE LASER (K992814)Cynosure, Inc.1999-09-15+ Add
TWILIGHT (K991994)Biolase Technology, Inc.1999-09-10+ Add
THERMALIGHT 2000 (K992630)Jennifermaxx, Inc.1999-09-10+ Add
CYNOSURE DIODERM (K992765)Cynosure, Inc.1999-09-08+ Add
DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER (K992013)Continuum Biomedical, Inc.1999-09-08+ Add
SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM (K992472)Clinicon Corp.1999-09-08+ Add
CERALAS D10 810NM DIODE LASER (K992773)Ceram Optec, Inc.1999-09-01+ Add
LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) (K990903)Laserscope1999-08-27+ Add
BLULAZE (K992620)Premier Laser Systems, Inc.1999-08-20+ Add
TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,SMA (K992508)Instruments For Medicine and Diagnostics1999-08-19+ Add
UM-L20/ UM-L30 (K982860)Union Medical Engeneering Co., Ltd.1999-08-13+ Add
FOTONA NOVALIS R RUBY LASER SYSTEM (K991634)Fotona D.D.1999-08-10+ Add
FOTONA NOVALIS ER: YAG LASER SYSTEM (K991632)Fotona D.D.1999-08-10+ Add
MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA (K991628)Esc Medical Systems, Inc.1999-08-09+ Add
DENTEC LD 15 DIODE LASER (K990680)Dentek Lasersystems Produktions Ges.M.B.H.1999-07-30+ Add
POLARIS DIODE LASER SYSTEM AND ACCESSORIES (K990914)Xintec Corporation1999-07-30+ Add
PULSTAR (K992061)Lasermed, Inc.1999-07-30+ Add
UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES (K991659)Medart Corp.1999-07-29+ Add
DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 (K991464)Fisma, Inc.1999-07-20+ Add
UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES (K991297)Medart Corp.1999-07-12+ Add
CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER (K992084)Cynosure, Inc.1999-07-12+ Add
OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP (K992230)Trimedyne, Inc.1999-07-12+ Add
LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE (K991285)Aesculap-Meditec North America1999-07-12+ Add
SCATTERFREE LATERAL EMITTING FIBER (K992083)Laser Peripherals, LLC1999-07-12+ Add
THE ACME MEDICAL AESTHETIC ND:YAG LASER (K991234)Acme Medical, Inc.1999-06-28+ Add
CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15 (K991891)Ceram Optec, Inc.1999-06-24+ Add
FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES (K990243)Fotona D.D.1999-06-09+ Add
DORNIER LASERTRODE FIBER (K991183)Dornier Surgical Products, Inc.1999-06-09+ Add
COOLTOUCH V ND:YAG (K983984)Laser Aesthetics, Inc.1999-06-07+ Add
MODIFICATION OF MLT R694 RUBY LASER SYSTEM (K990902)Medical Laser Technologies , Ltd.1999-05-27+ Add
SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 (K990568)Synergetics, Inc.1999-05-14+ Add
NOVUS VERDI DELIVERY SYSTEMS (K991258)Lumenis, Inc.1999-05-13+ Add
PULSEMASTER DENTAL LASER SYSTEM (K984486)American Dental Technologies, Inc.1999-05-13+ Add
EDGE SYSTEMS STERILE TUBING (K990748)Edge Systems Corp.1999-05-04+ Add
ORLIGHT 2000 SURGICAL LASER SYSTEM (K990452)Ybeam Technologies, Inc.1999-04-29+ Add
MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY (K990947)Lumenis, Inc.1999-04-27+ Add
DERMACOOL (K990417)Optomed Corp.1999-04-14+ Add
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (K982940)Star Medical Technologies, Inc.1999-04-08+ Add
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP) (K983524)Lares Research, Inc.1999-04-01+ Add
ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV (K990174)Fisma, Inc.1999-04-01+ Add
INDIGO LASEROPTIC TREATMENT SYSTEM (K990851)Indigo Medical, Inc.1999-03-30+ Add
DORNIER MEDILAS H/2 (K984591)Dornier Surgical Products, Inc.1999-03-26+ Add
NUVOLASE 532 LASER SYSTEM (K990725)American Laser Corp.1999-03-22+ Add
NUVOLASE 532 CUTANEOUS LASER SYSTEM (K990780)American Laser Medical1999-03-22+ Add
LOKKI DT (K980840)Hillard W. Welch1999-03-15+ Add
AURA DYE LASER SYSTEM (ADLS) (K984424)Laserscope1999-03-05+ Add
LIGHTSHEER LONG PULSE RUBY LASER (K982980)Palomar Medical Products, Inc.1999-03-04+ Add
DIOSCAN (K990014)Diomed, Inc.1999-02-26+ Add
MEDART 455 SCANNER SYSTEM (K984339)Del Mar Technologies, Inc.1999-02-18+ Add
SMOOTHLASE ALEXANDRITE LASER SYSTEM (K990043)Leisegang Medical, Inc.1999-02-11+ Add
MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER (K983054)Continuum Biomedical, Inc.1999-02-10+ Add
CANDELA GENTLELASE II DERMATOLOGICAL LASER (K984601)Candela Corp.1999-02-04+ Add
DORNIER MEDILAS R (K984349)Dornier1999-02-04+ Add
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