FDA Product Code
FDA Product Code GEX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 2,887 records · page 15 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K033251 | THE FRIENDLYLIGHT ND: YAG LASERS | Innotech USA, Inc. | 2004-03-02 | Traditional | PDF ↗ |
| K033259 | LIGHT AGE Q-CLEAR LASER, MODEL 701-1101 | Light Age, Inc. | 2004-02-25 | Traditional | PDF ↗ |
| K033962 | LAD (EPITURE EASYTOUCH), MODEL LAD-08 | Norwood Abbey , Ltd. | 2004-02-20 | Special | PDF ↗ |
| K033354 | FEMTEC LASER MICROKERATOME | 20/10 Perfect Vision Optische Gerate GmbH | 2004-02-18 | Traditional | PDF ↗ |
| K034030 | APOGEE ELITE | Cynosure, Inc. | 2004-02-09 | Traditional | PDF ↗ |
| K030523 | WATERLASE | Biolase Technology, Inc. | 2004-01-30 | Traditional | PDF ↗ |
| K032514 | AC APPLICATOR, AURORA AC | Syneron Medical, Ltd. | 2004-01-27 | Traditional | PDF ↗ |
| K032667 | FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) | Focus Medical, LLC | 2004-01-23 | Traditional | PDF ↗ |
| K033176 | TRISTAR AESTHETIC WORKSTATION LASER | Cynosure, Inc. | 2004-01-21 | Special | PDF ↗ |
| K033437 | SPHINX LASER SYSTEMS | Allmed Systems, Inc. | 2004-01-20 | Traditional | PDF ↗ |
| K033331 | CANDELA CBEAM PULSE DYE LASER SYSTEM | Candela Corp. | 2004-01-16 | Traditional | PDF ↗ |
| K033461 | CANDELA VBEAM PULSE DYE LASER SYSTEM | Candela Corp. | 2004-01-16 | Traditional | PDF ↗ |
| K033423 | REVOLIX LASER SYSTEMS | Allmed Systems, Inc. | 2004-01-15 | Traditional | PDF ↗ |
| K033799 | CLINICAL LASETTE P-200 | Cell Robotics, Inc. | 2003-12-22 | Special | PDF ↗ |
| K032944 | YA-MAN LASER 21 | Ya-Man, Ltd. | 2003-12-19 | Traditional | PDF ↗ |
| K032205 | RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY | Radiancy (Israel) , Ltd. | 2003-12-11 | Traditional | PDF ↗ |
| K032846 | SPECTRA PULSED DIODE LASER, MODEL DR-1 | Spectragenics, Inc. | 2003-12-11 | Traditional | PDF ↗ |
| K033586 | MODIFICATION TO AURORA DS | Syneron Medical, Ltd. | 2003-12-10 | Special | PDF ↗ |
| K030834 | CANDELA SMOOTHBEAM LASER SYSTEM | Candela Corp. | 2003-12-03 | Traditional | PDF ↗ |
| K032735 | SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM | Max Engineering , Ltd. | 2003-12-03 | Traditional | PDF ↗ |
| K031671 | POLARIS WR | Syneron Medical, Ltd. | 2003-12-01 | Traditional | PDF ↗ |
| K032383 | MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM | Curelight, Ltd. | 2003-11-28 | Traditional | PDF ↗ |
| K032260 | ARAMIS II DERMATOLOGICAL LASER | Quantel Medical | 2003-11-20 | Traditional | PDF ↗ |
| K033237 | VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE | Vascular Solutions, Inc. | 2003-11-20 | Traditional | PDF ↗ |
| K024206 | AURA ISURGICAL LASER SYSTEM & ACCESSORIES | Laserscope | 2003-11-17 | Traditional | PDF ↗ |
| K032539 | CYNOSURE PHOTOGENICA SV LASER | Cynosure, Inc. | 2003-11-17 | Traditional | PDF ↗ |
| K032460 | PROFILE BBL SYSTEM | Sciton, Inc | 2003-11-13 | Traditional | PDF ↗ |
| K031795 | RELIANT LASER SYSTEM | Reliant Technologies, Inc. | 2003-11-10 | Traditional | PDF ↗ |
| K031819 | DIO-DENT 10 DENTAL DIODE LASER | Msq (M2) , Ltd. | 2003-10-30 | Traditional | PDF ↗ |
| K033172 | CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS | Candela Corp. | 2003-10-30 | Traditional | PDF ↗ |
| K032599 | MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM | Medical Laser Technologies, LLC | 2003-10-29 | Traditional | PDF ↗ |
| K032703 | INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10 | Innovatech Surgical, Inc. | 2003-10-24 | Traditional | PDF ↗ |
| K032220 | ADEPT 1064/532 LASER | Adept Medical Concepts | 2003-10-24 | Traditional | PDF ↗ |
| K032218 | ADEPT 1064/532/755 LASER | Adept Medical Concepts | 2003-10-24 | Traditional | PDF ↗ |
| K032221 | ADEPT 1064/755 LASER | Adept Medical Concepts | 2003-10-24 | Traditional | PDF ↗ |
| K033181 | SPR SYSTEM | Radiancy (Israel) , Ltd. | 2003-10-24 | Traditional | PDF ↗ |
| K032704 | INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 | Innovatech Surgical, Inc. | 2003-10-24 | Traditional | PDF ↗ |
| K032565 | CYNOSURE PHOTOGENICA VL | Cynosure, Inc. | 2003-10-22 | Traditional | PDF ↗ |
| K030539 | LASERSMILE | Biolase Technology, Inc. | 2003-10-10 | Traditional | PDF ↗ |
| K032357 | NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES | Lumenis, Inc. | 2003-10-09 | Traditional | PDF ↗ |
| K031125 | CYNOSURE SMART FILE ND:YAG LASERS | Cynosure, Inc. | 2003-10-09 | Traditional | PDF ↗ |
| K032085 | GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 | Nidek, Inc. | 2003-10-03 | Traditional | PDF ↗ |
| K032805 | MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT | Vascular Solutions, Inc. | 2003-10-01 | Special | PDF ↗ |
| K032023 | W.O.M. LASER U100PLUS | W.O.M. World of Medicine AG | 2003-10-01 | Traditional | PDF ↗ |
| K031440 | SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER | Cynosure, Inc. | 2003-10-01 | Traditional | PDF ↗ |
| K031389 | CYNOSURE SMART 2940D ER:YAG LASER | Cynosure, Inc. | 2003-10-01 | Traditional | PDF ↗ |
| K031960 | INTRALASE FS LASER | Intra Lase Corp. | 2003-09-29 | Traditional | PDF ↗ |
| K030846 | CANDELA SMOOTHBEAM LASER SYSTEM | Candela Corp. | 2003-09-16 | Traditional | PDF ↗ |
| K031805 | BLU-U, MODEL 4170 | Dusa Pharmaceuticals, Inc. | 2003-09-09 | Traditional | PDF ↗ |
| K031954 | COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS | New Star Lasers, Inc. | 2003-08-21 | Traditional | PDF ↗ |
| K032191 | OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM | Luxsano AB | 2003-08-20 | Special | PDF ↗ |
| K032204 | MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT | Vascular Solutions, Inc. | 2003-08-20 | Special | PDF ↗ |
| K031489 | PITANGA | Syneron Medical, Ltd. | 2003-08-19 | Traditional | PDF ↗ |
| K031993 | AURORA SR | Syneron Medical, Ltd. | 2003-08-01 | Special | PDF ↗ |
| K031451 | XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000 | Photo Medex, Inc. | 2003-08-01 | Traditional | PDF ↗ |
| K031988 | AURORA DS | Syneron Medical, Ltd. | 2003-08-01 | Special | PDF ↗ |
| K030033 | LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES | Lumenis, Ltd. | 2003-07-21 | Traditional | PDF ↗ |
| K030342 | LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS | Lumenis, Ltd. | 2003-07-17 | Traditional | PDF ↗ |
| K030426 | OMNILUX RED | Photo Therapeutics Limited | 2003-07-17 | Traditional | PDF ↗ |
| K031258 | CYNOSURE PHOTOLIGHT PL | Cynosure, Inc. | 2003-07-08 | Traditional | PDF ↗ |
| K031690 | CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM) | Cynosure, Inc. | 2003-07-08 | Traditional | PDF ↗ |
| K024204 | FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM | Fotona D.D. | 2003-07-07 | Traditional | PDF ↗ |
| K031680 | SPECTRAPULSE | Primary Technology, LLC | 2003-06-24 | Traditional | PDF ↗ |
| K024259 | PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 | New Star Lasers, Inc. | 2003-06-20 | Traditional | PDF ↗ |
| K024189 | NLITE SYSTEM, MODEL#: A00-1025/A00-1033 | Icn Photonics , Ltd. | 2003-06-20 | Traditional | PDF ↗ |
| K024093 | MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS | Lumenis, Ltd. | 2003-06-19 | Traditional | PDF ↗ |
| K030897 | SKINSTATION | Radiancy (Israel) , Ltd. | 2003-06-19 | Traditional | PDF ↗ |
| K030654 | VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT | Vascular Solutions, Inc. | 2003-06-18 | Traditional | PDF ↗ |
| K031233 | ANDIODYNAMICS, INC. ELVS PROCEDURE KIT | AngioDynamics, Inc. | 2003-06-18 | Traditional | PDF ↗ |
| K030883 | OMNILUX BLUE | Photo Therapeutics Limited | 2003-06-18 | Traditional | PDF ↗ |
| K023881 | PROFILE 1064 LASER SYSTEM | Sciton, Inc | 2003-06-13 | Traditional | PDF ↗ |
| K030700 | CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT | Biolitec, Inc. | 2003-06-04 | Traditional | PDF ↗ |
| K031488 | CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER | Cynosure, Inc. | 2003-06-04 | Traditional | PDF ↗ |
| K031317 | SMART 2940 D ER: YAG LASER | Cynosure, Inc. | 2003-05-22 | Special | PDF ↗ |
| K031184 | COOL TOUCH 3 | New Star Lasers, Inc. | 2003-05-21 | Special | PDF ↗ |
| K030805 | MYTHOS 500 | Msq (M2) , Ltd. | 2003-05-21 | Traditional | PDF ↗ |
| K030527 | LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS | Lumenis | 2003-05-20 | Traditional | PDF ↗ |
| K030508 | DEPILASE TRIO LASE LASER SYSTEM | Depilase Group , Ltd. | 2003-05-20 | Traditional | PDF ↗ |
| K030510 | DEPILASE TWIN YAG LASER SYSTEM | Depilase Group , Ltd. | 2003-05-14 | Traditional | PDF ↗ |
| K030480 | L600 HAIR REMOVAL | A&M Technology | 2003-05-14 | Traditional | PDF ↗ |
| K030453 | COOLTOUCH ND: YAG LASER SYSTEM | New Star Lasers, Inc. | 2003-05-12 | Traditional | PDF ↗ |
| K030423 | POWERLITE 600 EP SYSTEM | Preswede AB | 2003-05-09 | Traditional | PDF ↗ |
| K031224 | SMARTXIDE | Cynosure, Inc. | 2003-05-09 | Special | PDF ↗ |
| K030506 | DEPILASE YAG LASE PLUS LASER SYSTEM | Depilase Group , Ltd. | 2003-05-09 | Traditional | PDF ↗ |
| K023734 | ARAMIS II DERMATOLOGICAL LASER | Quantel Medical | 2003-05-06 | Traditional | PDF ↗ |
| K030959 | BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 | Laser Peripherals, LLC | 2003-04-25 | Special | PDF ↗ |
| K030235 | F1 DIODE LASER SYSTEM | Opus Medical, Inc. | 2003-04-23 | Traditional | PDF ↗ |
| K030181 | INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM | International Biophysics Corp. | 2003-04-17 | Traditional | PDF ↗ |
| K030147 | LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS | Lumenis, Ltd. | 2003-04-15 | Traditional | PDF ↗ |
| K023547 | DIOLASE 980 D LASER SYSTEM | American Dental Technologies, Inc. | 2003-04-15 | Traditional | PDF ↗ |
| K030186 | POLRIS LV | Syneron Medical, Ltd. | 2003-04-14 | Traditional | PDF ↗ |
| K024371 | CANDELA GENTLE LASE FAMILY OF LASER SYSTEM | Candela Corp. | 2003-03-31 | Traditional | PDF ↗ |
| K023257 | ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX | Prosurg, Inc. | 2003-03-28 | Traditional | PDF ↗ |
| K024260 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | Candela Corp. | 2003-03-21 | Traditional | PDF ↗ |
| K023954 | ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES | Altus Medical, Inc. | 2003-03-18 | Traditional | PDF ↗ |
| K022923 | CANDELA GENTLE YAG LASER SYSTEM | Candela Corp. | 2003-03-13 | Traditional | PDF ↗ |
| K024335 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | Candela Corp. | 2003-03-12 | Traditional | PDF ↗ |
| K024061 | PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 | Peregrine Surgical , Ltd. | 2003-03-07 | Traditional | PDF ↗ |
| K023899 | DUAL YELLOW LASER, MODEL D10B | Norseld Pty., Ltd. | 2003-02-20 | Traditional | PDF ↗ |
| K022709 | MEDLITE Q-SWITHCED LASER | Continuum Electro-Optics, Inc. | 2003-02-20 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.