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 20 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K974633 | SCANTECH LASER SCANNER | Phantom Technologies, Inc. | 1998-01-16 | Traditional | PDF ↗ |
| K974346 | STARLIGHT PULSED DIODE ARRAY LASER SYSTEM | Star Medical Technologies, Inc. | 1998-01-16 | Traditional | PDF ↗ |
| K974039 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE | Schwartz Electro-Optics, Inc. | 1998-01-12 | Traditional | PDF ↗ |
| K973828 | PRIMA KTP LASER SYSTEM | Nidek, Inc. | 1998-01-05 | Traditional | PDF ↗ |
| K973764 | TEMPERATURE DIAGNOSTIC ACCESSORY | New Star Lasers, Inc. | 1997-12-31 | Traditional | PDF ↗ |
| K963969 | INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB | Indigo Medical, Inc. | 1997-12-23 | Traditional | PDF ↗ |
| K973719 | MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER | Continuum Biomedical, Inc. | 1997-12-23 | Traditional | PDF ↗ |
| K973603 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM | Schwartz Electro-Optics, Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K972915 | ERBIUM 2000 LASER FAMILY | Phantom Technologies, Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K971118 | ARAGO | Premier Laser Systems, Inc. | 1997-12-16 | Traditional | PDF ↗ |
| K973470 | COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS | Lumenis, Inc. | 1997-12-09 | Traditional | PDF ↗ |
| K973576 | EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM | Epulse Technologies, Inc. | 1997-12-09 | Traditional | PDF ↗ |
| K973354 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) | Sharplan Lasers, Inc. | 1997-12-04 | Traditional | PDF ↗ |
| K972767 | CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER | Candela Corp. | 1997-12-04 | Traditional | PDF ↗ |
| K973324 | STARLIGHT PULSED DIODE ARRAY LASER SYSTEM | Star Medical Technologies, Inc. | 1997-12-03 | Traditional | PDF ↗ |
| K973498 | CYNOSURE PHOTOGENICA ER LASER | Cynosure, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K971912 | PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES | Xintec Corporation | 1997-11-03 | Traditional | PDF ↗ |
| K970143 | C4 | Clinicon Corp. | 1997-10-29 | Traditional | PDF ↗ |
| K973431 | LASETTE | Cell Robotics, Inc. | 1997-10-28 | Traditional | PDF ↗ |
| K972872 | DERMA K LASER SYSTEM | Esc Medical Systems , Ltd. | 1997-10-28 | Traditional | PDF ↗ |
| K972028 | DERMASCAN SURGICAL LASER SCANNER | Esc Medical Systems , Ltd. | 1997-10-24 | Traditional | PDF ↗ |
| K972765 | NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER | American Laser Medical | 1997-10-21 | Traditional | PDF ↗ |
| K972561 | NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY | American Laser Medical | 1997-10-06 | Traditional | PDF ↗ |
| K970475 | MM-RUBY | American Lasers, Inc. | 1997-09-29 | Traditional | PDF ↗ |
| K971821 | UNICA 315 M CO2 SURGICAL LASER SYSTEM | Reliant Technologies, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K972368 | FOTONA SKINLIGHT PLUS ND: YAG SYSTEM | Medical Laser Solutions | 1997-09-23 | Traditional | PDF ↗ |
| K972325 | PULSEMASTER 1000 ST DENTAL LASER SYSTEM | American Dental Technologies, Inc. | 1997-09-19 | Traditional | PDF ↗ |
| K972347 | MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER | Lumenis, Inc. | 1997-09-19 | Traditional | PDF ↗ |
| K970808 | MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER | Continuum Biomedical, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K972099 | SHARPLAN EPITOUCH RUBY LASER SYSTEM | Sharplan Lasers, Inc. | 1997-08-27 | Traditional | PDF ↗ |
| K972002 | CYNOSURE DERMATOLOGY LASER COOLING TIP | Cynosure, Inc. | 1997-08-27 | Traditional | PDF ↗ |
| K971903 | SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER | Continuum Biomedical, Inc. | 1997-08-21 | Traditional | PDF ↗ |
| K971874 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) | Sharplan Lasers, Inc. | 1997-08-18 | Traditional | PDF ↗ |
| K971830 | ACCU-PULSE CARBON DIOXIDE LASER SYSTEM | Argus Photonics Group | 1997-08-14 | Traditional | PDF ↗ |
| K965124 | LASETTE | Cell Robotics, Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K971879 | SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER | Continuum Biomedical, Inc. | 1997-08-14 | Traditional | PDF ↗ |
| K971737 | CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER | Cynosure, Inc. | 1997-08-08 | Traditional | PDF ↗ |
| K964831 | SURESCAN | Clinicon Corp. | 1997-08-08 | Traditional | PDF ↗ |
| K971814 | IMPROVEMENTS TO THE MEHL RUBY LASER | Mehl/Biophile Intl., Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K972272 | LASER PERIPHERALS HOLMIUM BARE FIBERS | Laser Peripherals, LLC | 1997-07-29 | Traditional | PDF ↗ |
| K971843 | LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES | Laserscope | 1997-07-23 | Traditional | PDF ↗ |
| K971648 | SHARPLAN ERBIUM: YAG LASER (4020) | Sharplan Lasers, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K971743 | SHARPLAN CO2 SURGICAL LASER SYSTEM | Sharplan Lasers, Inc. | 1997-07-18 | Traditional | PDF ↗ |
| K971459 | DERMALASE | Endo Technic Corp. | 1997-07-18 | Traditional | PDF ↗ |
| K965128 | CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER | Cynosure, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K970461 | CELL ROBOTICS ER: YAG SURGICAL LASER | Cell Robotics, Inc. | 1997-07-11 | Traditional | PDF ↗ |
| K971404 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER | Schwartz Electro-Optics, Inc. | 1997-07-09 | Traditional | PDF ↗ |
| K963249 | EPILIGHT HAIR REMOVAL SYSTEM | Esc Medical Systems , Ltd. | 1997-07-07 | Traditional | PDF ↗ |
| K971250 | LASERSCOPE MICROBEAM IV MICROMANIPULATOR | Laserscope | 1997-06-30 | Traditional | PDF ↗ |
| K971193 | LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM | Polytec Pi, Inc. | 1997-06-24 | Traditional | PDF ↗ |
| K971065 | DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES | Xintec Corporation | 1997-06-17 | Traditional | PDF ↗ |
| K971024 | SOFTSCAN | Sahar Technologies, Inc. | 1997-06-17 | Traditional | PDF ↗ |
| K964818 | ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION) | Laserscope | 1997-06-17 | Traditional | PDF ↗ |
| K970934 | CB ERBIUM/2.94(TM) ER:YAG LASER | Continuum Biomedical, Inc. | 1997-06-11 | Traditional | PDF ↗ |
| K965180 | STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000) | Myriad Lase, Inc. | 1997-06-05 | Traditional | PDF ↗ |
| K970243 | CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR | Cynosure, Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K970804 | TRU-PULSE CO2 SURGICAL LASER | Tissue Technologies, Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K971539 | NOVATIP FAMILY OF LASER HANDPIECE TIPS | Xanova Corp. | 1997-06-03 | Traditional | PDF ↗ |
| K970948 | 800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES | Laserscope | 1997-05-21 | Traditional | PDF ↗ |
| K970667 | NUVO-LASE 660 LASER SYSTEM | American Laser Medical | 1997-05-13 | Traditional | PDF ↗ |
| K963340 | MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE | Continuum Biomedical, Inc. | 1997-05-12 | Traditional | PDF ↗ |
| K970757 | FOTONA SKINSCAN | Medical Laser Solutions | 1997-05-09 | Traditional | PDF ↗ |
| K932683 | CENTAURI | Premier Laser Systems, Inc. | 1997-05-05 | Traditional | PDF ↗ |
| K933841 | CENTAURI | Premier Laser Systems, Inc. | 1997-05-05 | Traditional | PDF ↗ |
| K963996 | (FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400 | Full Spectrum, Inc. | 1997-04-24 | Traditional | PDF ↗ |
| K963991 | FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS | Full Spectrum, Inc. | 1997-04-24 | Traditional | PDF ↗ |
| K970422 | RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS | Trimedyne, Inc. | 1997-04-21 | Traditional | PDF ↗ |
| K964585 | RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) | Trimedyne, Inc. | 1997-04-17 | Traditional | PDF ↗ |
| K964253 | DERMA 20 LASER SYSTEM | Esc Medical Systems , Ltd. | 1997-04-11 | Traditional | PDF ↗ |
| K955653 | VENISECT LASER LANCET | Venisect, Inc. | 1997-04-11 | Traditional | PDF ↗ |
| K970157 | LASERSCOPE AUTOMATIC EYE PROTECTION FILTER | Laserscope | 1997-04-07 | Traditional | PDF ↗ |
| K970637 | ACCUCURE 1000 | Lasermed, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K964074 | DIOLITE 532 | Iriderm Div. | 1997-04-01 | Traditional | PDF ↗ |
| K970017 | NIDEK CYBERSCAN | Nidek, Inc. | 1997-03-18 | Traditional | PDF ↗ |
| K970361 | LASER EYE GOGGLES | Stefanovsky & Assoc. | 1997-03-18 | Traditional | PDF ↗ |
| K964128 | MCL 29 DERMABLATE ERBIUM LASER SYSTEM | Aesculap-Meditec GmbH | 1997-03-17 | Traditional | PDF ↗ |
| K961380 | CPC PROBE | Carl Zeiss, Inc. | 1997-03-17 | Traditional | PDF ↗ |
| K965015 | TOPAZ 30 SURGICAL LASER SYSTEM | Esc Medical Systems, Inc. | 1997-03-14 | Traditional | PDF ↗ |
| K962791 | NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM | New Star Lasers, Inc. | 1997-03-13 | Traditional | PDF ↗ |
| K962109 | SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL | Classy Lady by Mehl of Puerto Rico, Inc. | 1997-03-13 | Traditional | PDF ↗ |
| K961269 | PULSEMASTER | American Dental Technologies, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K962446 | SHARPLAN RUBY LASER SYSTEM | Sharplan Lasers, Inc. | 1997-03-07 | Traditional | PDF ↗ |
| K963947 | EPILASER NORMAL MODE RUBY LASER | Spectrum Medical Technologies, Inc. | 1997-03-05 | Traditional | PDF ↗ |
| K964353 | CYBERLASE CO2 LASER SYSTEM | Nidek, Inc. | 1997-02-28 | Traditional | PDF ↗ |
| K963081 | INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS | Indigo Medical, Inc. | 1997-02-21 | Traditional | PDF ↗ |
| K964760 | DORNIER MEDILAS FIBER TOME LASER | Dornier Medtech America, Inc. | 1997-02-19 | Traditional | PDF ↗ |
| K964486 | ACCUCURE 3000 | Lasermed, Inc. | 1997-02-18 | Traditional | PDF ↗ |
| K964684 | SOFTOUCH | Sahar Technologies, Inc. | 1997-02-14 | Traditional | PDF ↗ |
| K963683 | TRU-PULSE LASER (MODIFIED) | Tissue Technologies, Inc. | 1997-02-12 | Traditional | PDF ↗ |
| K964520 | PARASCAN SCANNING DEVICE | Laserscope | 1997-02-10 | Traditional | PDF ↗ |
| K964497 | CERALAS DIODE LASER SYSTEM (CERALAS D15) | Ceram Optec, Inc. | 1997-02-06 | Traditional | PDF ↗ |
| K961560 | ECLIPSE 2000 | Cardiogenes | 1997-01-27 | Traditional | PDF ↗ |
| K963339 | COHERENT ULTRAPULSE CO2 SURGICAL LASERS | Coherent Medical Group | 1997-01-22 | Traditional | PDF ↗ |
| K962632 | OMNIPULSE/OMNIPULSE-MAX | Trimedyne, Inc. | 1997-01-16 | Traditional | PDF ↗ |
| K962902 | FOTONA SKINLIGHT LASER SYSTEM | Medical Laser Solutions | 1997-01-10 | Traditional | PDF ↗ |
| K962965 | LIGHTSTIC MODEL 360 | Rare Earth Medical, Inc. | 1997-01-09 | Traditional | PDF ↗ |
| K964076 | LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES | Laserscope | 1997-01-08 | Traditional | PDF ↗ |
| K964031 | DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM | Slt-J , Ltd. | 1996-12-23 | Traditional | PDF ↗ |
| K963094 | CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER | Cynosure, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K964211 | DAVOL PLUME FILTER (5541420) | Davol Inc., Sub. C. R. Bard, Inc. | 1996-12-02 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.