Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 28
- Latest Decision
- 2008-07-03
Clearances · page 60 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K080972 | ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP | Ethicon Endo-Sugery, LLC | GDW | Class II | 2008-07-03 |
| K080287 | ONCOBIONIC BIPOLAR ELECTRODE | AngioDynamics, Inc. | GEI | Class II | 2008-07-03 |
| K080451 | UNIBLATE ELECTROSURGICAL DEVICE | AngioDynamics, Inc. | GEI | Class II | 2008-07-03 |
| K080915 | FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | GEX | Class II | 2008-07-01 |
| K081219 | APOLLO MINI IPL SYSTEM | Sandstone Medical Technologies, LLC | GEX | Class II | 2008-06-30 |
| K072182 | ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060 | Alma Lasers , Ltd. | GEX | Class II | 2008-06-27 |
| K080959 | DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 | Dornier Medtech America, Inc. | GEX | Class II | 2008-06-27 |
| K072962 | CABS'AIR | Cousin Biotech Sas | FTL | Class II | 2008-06-26 |
| K081146 | ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT) | Ethicon Endo-Surgery, LLC | GDW | Class II | 2008-06-26 |
| K081634 | CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL | Conmed Corporation | GEI | Class II | 2008-06-25 |
| K080962 | LITE WAND II | Thompson Surgical Instruments, Inc. | FST | Class II | 2008-06-25 |
| K081612 | AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS | Aesculight, LLC | GEX | Class II | 2008-06-25 |
| K080197 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM | Plasma Surgical, Ltd. | GEI | Class II | 2008-06-24 |
| K081628 | MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO | New Star Lasers, Inc. | GEX | Class II | 2008-06-20 |
| K080244 | PALOMAR LUX 1540 HANDPIECE | Palomar Medical Products, Inc. | GEX | Class II | 2008-06-20 |
| K081578 | ACCELA SYSTEM | Genesis Biosystems, Inc. | GEX | Class II | 2008-06-20 |
| K081580 | BEAMER ARGON SNARE PROBE | Conmed Corporation | GEI | Class II | 2008-06-19 |
| K081327 | RELIMESH | Herniamesh S.R.L. | FTL | Class II | 2008-06-19 |
| K081538 | TUTOPATCH, TUTOMESH | Rti Biologics, Inc. | FTM | Class II | 2008-06-19 |
| K072560 | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) | Teikoku Pharma USA, Inc. | NAD | Class I | 2008-06-17 |
| K081324 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS | Candela Corp. | GEX | Class II | 2008-06-17 |
| K081589 | WATERLASE, VERSION 3.0 | Biolase Technology, Inc. | GEX | Class II | 2008-06-13 |
| K080932 | MOSAIC LASER SYSTEM | Lutronic Corporation | GEX | Class II | 2008-06-09 |
| K081001 | PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE | Sutures India Pvt., Ltd. | NEW | Class II | 2008-06-09 |
| K080684 | WG-SURGICAL SUTURES WITH NEEDLE | Foosin Medical Supplies, Inc. | GAP | Class II | 2008-06-09 |
| K081002 | MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE | Sutures India Pvt., Ltd. | GAM | Class II | 2008-06-09 |
| K081003 | TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE | Sutures India Pvt., Ltd. | GAM | Class II | 2008-06-09 |
| K081069 | GORE INFINIT MESH | W. L. Gore & Associates, Inc. | FTL | Class II | 2008-05-30 |
| K081416 | PALOMAR ASPIRE LASER PLATFORM | Palomar Medical Products, Inc. | GEX | Class II | 2008-05-29 |
| K081170 | PROSTATE TISSUE MARKER | Senorx, Inc. | NEU | Class II | 2008-05-28 |
| K081050 | PARIETEX PROGRIP MESH | Sofradim Production | FTL | Class II | 2008-05-28 |
| K072859 | ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES | Internacional Farmaceutica, S.A. DE C.V. | GAM | Class II | 2008-05-23 |
| K072863 | ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES | Internacional Farmaceutica, S.A. DE C.V. | GAM | Class II | 2008-05-23 |
| K072564 | ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM | Alma Lasers , Ltd. | GEX | Class II | 2008-05-23 |
| K080839 | ECHELON GRAY CARTRIDGE, MODEL ERC45M | Ethicon Endo-Surgery, LLC | GDW | Class II | 2008-05-21 |
| K080452 | COLLAGEN TENDON WRAP | Collagen Matrix, Inc. | FTM | Class II | 2008-05-15 |
| K080374 | BIOSYAG MEDICAL SYSTEM | Bios S.R.L. | GEX | Class II | 2008-05-15 |
| K081214 | STYLA MICROLASER AND STYLAORTHO | Zap Lasers, LLC | GEX | Class II | 2008-05-14 |
| K073411 | LITEDUO | Light Instruments | GEX | Class II | 2008-05-13 |
| K080674 | PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM | PAJUNK GmbH Medizintechnologie | MJG | Class I | 2008-05-09 |
| K073477 | PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS | Photonova Ofsweden AB | GEX | Class II | 2008-05-09 |
| K080359 | EVOLUTION ESOPHAGEAL STENT SYSTEM | Cook Ireland, Ltd. | ESW | Class II | 2008-05-09 |
| K080187 | OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS | Olsen Medical | GEI | Class II | 2008-05-09 |
| K073207 | OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 | Celon AG Medical Instruments | GEI | Class II | 2008-05-08 |
| K080202 | ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT | Oncobionics, Inc. | OAB | Class II | 2008-05-08 |
| K072456 | DESARA MESH SLING, MODEL CAL-DS01 | Caldera Medical, Inc. | OTN | Class II | 2008-05-08 |
| K081082 | U-CLIP UNI-FIRE, MODEL M65 | Medtronic, Inc. | FZP | Class II | 2008-05-07 |
| K073493 | HEPATOSTAT SET | Vygon Corp. | GAM | Class II | 2008-05-06 |
| K081181 | SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER | Cynosure, Inc. | GEX | Class II | 2008-05-05 |
| K080509 | CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE | Medtronic, Inc. | OCL | Class II | 2008-05-05 |
| K080898 | AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT | Tyco Healthcare Group LP | GDW | Class II | 2008-05-05 |
| K081031 | ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE | Aesculap, Inc. | FZP | Class II | 2008-05-05 |
| K081185 | MOBLVAC W.C. | Ohio Medical Corporation | BTA | Class II | 2008-05-02 |
| K080093 | PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK | Gyrus Acmi, Inc. | GEI | Class II | 2008-05-02 |
| K080158 | LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM | Lb Medical LLC | FZW | Class I | 2008-05-02 |
| K080118 | ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE | Zeltiq Aesthetics | GEX | Class II | 2008-05-02 |
| K073614 | WG-SURGICAL SUTURES WITH NEEDLE | Foosin Medical Supplies, Inc. | NEW | Class II | 2008-04-30 |
| K072930 | DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT | Demetech Corp. | GAL | Class II | 2008-04-30 |
| K080845 | ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM | Cardinalhealth | JCX | Class II | 2008-04-30 |
| K081047 | TRANSPOSAL ULTRA SYSTEMS | Dornoch Medical Systems, Inc. | JCX | Class II | 2008-04-29 |
| K073404 | IFS LASER SYSTEM | Intra Lase Corp. | GEX | Class II | 2008-04-25 |
| K080838 | ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | Alveolus, Inc. | ESW | Class II | 2008-04-24 |
| K080627 | PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A | Promedical Products Co., Ltd. | FYA | Class II | 2008-04-24 |
| K080005 | SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 | Ding Hwa Co., Ltd. | JCX | Class II | 2008-04-24 |
| K073447 | SURGI GLOVES | Metacure Surgical Gloves Sdn Bhd | KGO | Class I | 2008-04-24 |
| K080248 | SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES | Lutronic Corporation | GEX | Class II | 2008-04-23 |
| K080918 | DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0 | Depuy Mitek | NEW | Class II | 2008-04-23 |
| K080985 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) | Surgical Specialties Corp | NEW | Class II | 2008-04-23 |
| K080524 | CENTURION SORBAVIEW OTC | Tri-State Hospital Supply Corp. | NAD | Class I | 2008-04-23 |
| K073715 | ELIPO | Syneron Medical, Ltd. | GEX | Class II | 2008-04-23 |
| K080836 | MODIFICATION TO ENDOFAST RELIANT SYSTEM | Endogun Medical Systems | FTL | Class II | 2008-04-21 |
| K080507 | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT | Ceremed , Inc. | KKY | Class II | 2008-04-21 |
| K072682 | 50W CERALAS D 1950NM DIODE LASER | Biolitec, Inc. | GEX | Class II | 2008-04-18 |
| K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W | Cook Urological, Inc. | GEX | Class II | 2008-04-17 |
| K080691 | C-QUR EDGE MESH V-PATCH | Atrium Medical Corp. | FTL | Class II | 2008-04-16 |
| K080688 | C-QUR LITE MESH V-PATCH | Atrium Medical Corp. | FTL | Class II | 2008-04-16 |
| K072814 | CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES | Covidien | KDD | Class I | 2008-04-16 |
| K080567 | PALOMAR ASPIRE LASER PLATFORM | Palomar Medical Products, Inc. | GEX | Class II | 2008-04-16 |
| K080857 | CHROMOPHARE E-SERIES | Berchtold Holding GmbH | FSY | Class II | 2008-04-10 |
| K073219 | WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 | American Medical Systems, Inc. | FTM | Class II | 2008-04-10 |
| K080163 | COOLTOUCH MODELS LC215 AND COOLLIPO | New Star Lasers, Inc. | GEX | Class II | 2008-04-10 |
| K072041 | BOVIE IDS-400 ELECTROSURGICAL GENERATOR | Bovie Medical | GEI | Class II | 2008-04-10 |
| K073617 | PHARAON LIPO | Osyris | GEX | Class II | 2008-04-09 |
| K080300 | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) | Cutera, Inc. | NUV | Class II | 2008-04-08 |
| K080697 | SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER | Global USA Distribution, LLC | GEX | Class II | 2008-04-07 |
| K080827 | HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 | Handan Hengyong Protective & Clean Products Co., L | MSH | Class II | 2008-04-04 |
| K080735 | CRYOMINI | Zimmer Elektromedizin GmbH | GEX | Class II | 2008-04-04 |
| K080353 | LTM-T SURGICAL MESH | Lifecell Corp. | FTL | Class II | 2008-04-03 |
| K073534 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS | Candela Corp. | GEX | Class II | 2008-04-03 |
| K080376 | ONCOBIONIC SYSTEM | Oncobionic Incorporated | OAB | Class II | 2008-04-02 |
| K080715 | ERBE VIO ESU, MODEL VIO 200 S | Erbe USA, Inc. | GEI | Class II | 2008-04-02 |
| K080753 | AESCULAP ENDOSCOPIC CLIP SYTEM | Aesculap, Inc. | FZP | Class II | 2008-04-02 |
| K080557 | BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS | Barrx Medical, Incorporated | GEI | Class II | 2008-04-02 |
| K080698 | GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP | Senorx, Inc. | NEU | Class II | 2008-03-31 |
| K080610 | ARTHROCARE ORTHOWAND SURGICAL DEVICE | Arthrocare Corp. | GEI | Class II | 2008-03-31 |
| K073111 | PORTRAIT PSR, MODEL 745915 | Rhytec Incorporated | GEI | Class II | 2008-03-27 |
| K080717 | HABIB HEXABLATE 10 | Emcision , Ltd. | GEI | Class II | 2008-03-27 |
| K080104 | VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542 | Vascular Solutions, Inc. | GEX | Class II | 2008-03-26 |
| K073583 | MODIFICATION TO PALOMAR LUX1540 HANDPIECE | Palomar Medical Products, Inc. | GEX | Class II | 2008-03-26 |
| K073455 | E-VAC | New Leaf Medical, Inc. | GEI | Class II | 2008-03-25 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.