Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 31
- Latest Decision
- 2002-12-06
Clearances · page 77 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K021548 | FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM | Fotona D.D. | GEX | Class II | 2002-12-06 |
| K023757 | CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 | Endocare, Inc. | GEH | Class II | 2002-12-05 |
| K021501 | V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT | Kinetic Concepts, Inc. | OMP | Class II | 2002-12-02 |
| K023543 | EVLT KIT AND D15PLUS AND D30PLUS DIODE | Diomed, Inc. | GEX | Class II | 2002-12-02 |
| K023767 | UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES | The Olympus Optical Co. | GEI | Class II | 2002-11-29 |
| K023765 | STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | Stellartech Research Corp. | GEI | Class II | 2002-11-29 |
| K023812 | NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085 | Erbe USA, Inc. | GEI | Class II | 2002-11-29 |
| K023647 | CADENCE PEEK CEMEENT RESTRICTOR | Spinal Concepts, Inc. | JDK | Class II | 2002-11-27 |
| K022839 | FOTONA DUALIS PLUS ND:YAG LASER SYSTEM | Fotona D.D. | GEX | Class II | 2002-11-25 |
| K023029 | DEMETECH SILK NONABSORBABLE SUTURE | Demetech Corp. | GAP | Class II | 2002-11-25 |
| K022838 | FOTONA DUALIS ER:YAG/KTP LASER SYSTEM | Fotona D.D. | GEX | Class II | 2002-11-25 |
| K022837 | FOTONA TANDEM LASER SYSTEM | Fotona D.D. | GEX | Class II | 2002-11-25 |
| K022989 | RADLITE TISSUE RETRACTOR SYSTEM | Genzyme Biosurgery | FSW | Class II | 2002-11-25 |
| K022817 | COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II | Icn Pharmaceuticals, Inc. | GEX | Class II | 2002-11-22 |
| K022464 | EQUILASE SYSTEM | Equilasers, Inc. | GEX | Class II | 2002-11-21 |
| K021444 | CYNOSURE PHOTOGENICA SV | Cynosure, Inc. | GEX | Class II | 2002-11-20 |
| K023516 | MONARC SLING SYSTEM | American Medical Systems, Inc. | OTN | Class II | 2002-11-19 |
| K021767 | ASSUFIL | Assut Europe S.P.A. | GAM | Class II | 2002-11-19 |
| K020804 | AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER | United States Surgical, A Division of Tyco Healthc | GDW | Class II | 2002-11-19 |
| K022777 | MANUAL TOUCHE SYSTEM | Onux Medical, Inc. | GAQ | Class II | 2002-11-19 |
| K023601 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 | Rubicor Medical, Inc. | GEI | Class II | 2002-11-19 |
| K023680 | BIOBUCK CEMENT RESTRICTOR | Smith & Nephew, Inc. | LZN | Class II | 2002-11-19 |
| K023635 | SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN | Sri/Surgical Express, Inc. | FYA | Class II | 2002-11-18 |
| K022760 | MILLENNIUM MICROSURGICAL SYSTEM | Bausch & Lomb, Inc. | GEX | Class II | 2002-11-18 |
| K023492 | EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS | Gyrus Medical, Inc. | GEI | Class II | 2002-11-13 |
| K023493 | PK ZIP WING CUTTING DISSECTOR | Gyrus Medical, Inc. | GEI | Class II | 2002-11-13 |
| K021585 | STELLAR SERIES SURGICAL LIGHTS WITH HERMES | Skytron, Div. the Kmw Group, Inc. | FSY | Class II | 2002-11-13 |
| K022059 | MICROVASIVE PULMONARY GUIDEWIRE | Boston Scientific Corp | MDM | Class I | 2002-11-13 |
| K023236 | SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | Maxxim Medical | KGO | Class I | 2002-11-12 |
| K022868 | PRIMAGARD SURGICAL EQUIPMENT DRAPES | Primeline Medical Products, Inc. | KKX | Class II | 2002-11-08 |
| K023266 | PRIMAGARD SURGICAL GOWNS | Primeline Medical Products, Inc. | FYA | Class II | 2002-11-08 |
| K023117 | PRIMAGARD SURGICAL GOWNS | Primeline Medical Products, Inc. | KKX | Class II | 2002-11-08 |
| K023413 | MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM | Neothermia Corp. | GEI | Class II | 2002-11-08 |
| K022655 | TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH | Trimedyne, Inc. | GEX | Class II | 2002-11-07 |
| K021434 | ARTHREX FIBERWIRE IN USP SIZES | Arthrex, Inc. | GAT | Class II | 2002-11-07 |
| K023425 | DRAPES WITH ABSORBENT REINFORCEMENT | Allegiance Healthcare Corp. | KKX | Class II | 2002-11-06 |
| K021402 | THERMAGE THERMACOOL TC SYSTEM | Thermage, Inc. | GEI | Class II | 2002-11-05 |
| K022610 | CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160 | Clarus Medical, LLC | GEX | Class II | 2002-11-05 |
| K021467 | AUTOCON II 400 ELECTROSURGICAL GENERATOR | KARL STORZ Endoscopy-America, Inc. | GEI | Class II | 2002-11-04 |
| K023432 | MEDLINE ASEP PLUS SURGICAL DRAPES | Medline Industries, Inc. | KKX | Class II | 2002-11-04 |
| K021056 | PERMACOL | Tissue Science Laboratories, Plc | FTM | Class II | 2002-10-31 |
| K022583 | FLASH 1 | Emed, Inc. | GEX | Class II | 2002-10-31 |
| K022060 | LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES | Lumenis, Inc. | GEX | Class II | 2002-10-30 |
| K022615 | CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR | Centerpulse Spine-Tech, Inc. | JDK | Class II | 2002-10-29 |
| K020339 | DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM | Dornier Medtech America, Inc. | GEX | Class II | 2002-10-25 |
| K023182 | INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS | Ethicon Endo-Surgery, Inc. | GEX | Class II | 2002-10-24 |
| K022381 | PROFILE 1320 LASER SYSTEM | Sciton, Inc | GEX | Class II | 2002-10-18 |
| K022378 | PLASMALITE PULSED LIGHT SYSTEM | Medical Bio Care Sweden AB | GEX | Class II | 2002-10-18 |
| K023291 | COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X | Boston Scientific Corp | GEI | Class II | 2002-10-17 |
| K021835 | BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX | Brennen Medical, Inc. | FTL | Class II | 2002-10-17 |
| K022351 | DIODENT DENTAL LASER SYSTEM | Continuum Electro-Optics, Inc. | GEX | Class II | 2002-10-16 |
| K021889 | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) | Surgical Technology Laboratories, Inc. | KKY | Class II | 2002-10-16 |
| K022327 | NOVUS SPECTRA | Lumenis, Inc. | GEX | Class II | 2002-10-16 |
| K020054 | SANARUS INDICA MARKER SYSTEM | Sanarus Medical, Inc. | FZP | Class II | 2002-10-16 |
| K023136 | OLEEVA FABRIC | Bio Med Sciences, Inc. | MDA | Class I | 2002-10-16 |
| K022338 | OPTICAL INTEGRITY GENERAL SHAPED FIBER | Optical Integrity, Inc. | GEX | Class II | 2002-10-16 |
| K022314 | SANARUS VISICA TREATMENT SYSTEM | Sanarus Medical, Inc. | GEH | Class II | 2002-10-15 |
| K020839 | QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL | Lumenis, Inc. | GEX | Class II | 2002-10-11 |
| K022306 | AART SILICONE TUBING | Aesthetic and Reconstructive Technologies, Inc. | KGZ | Class I | 2002-10-10 |
| K022666 | PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. | Arc Medical Supplies (Beijing) Co, Ltd. | NEW | Class II | 2002-10-09 |
| K021329 | RITA SYSTEM | Rita Medical Systems | GEI | Class II | 2002-10-09 |
| K022665 | POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE | Hohenstein Enterprises, Inc. | KKY | Class II | 2002-10-09 |
| K022226 | ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS | Altus Medical, Inc. | GEX | Class II | 2002-10-08 |
| K022228 | FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES | Iridex Corp | GEX | Class II | 2002-10-08 |
| K021788 | NBD CEMENT RESTRICTOR DEVICE | New Business Development, LLC | JDK | Class II | 2002-10-04 |
| K014128 | CANDELA SMOOTHBEAM LASER SYSTEM | Candela Corp. | GEX | Class II | 2002-10-04 |
| K020334 | INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC | Jac-Cell Medic Corporation | GEI | Class II | 2002-10-03 |
| K022266 | AURORA SR | Syneron Medical, Ltd. | GEX | Class II | 2002-10-03 |
| K022475 | MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS | Arthrocare Corp. | GEI | Class II | 2002-10-03 |
| K023167 | BREATHABLE SURGICAL GOWN | Allegiance Healthcare Corp. | FYA | Class II | 2002-10-02 |
| K022181 | NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES | Lumenis, Inc. | GEX | Class II | 2002-10-01 |
| K020879 | IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001 | Integrated Vascular Systems, Inc. | FZP | Class II | 2002-09-25 |
| K013974 | RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A | Trimedyne, Inc. | GEX | Class II | 2002-09-23 |
| K021864 | PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142) | Primeline Medical Products, Inc. | KKX | Class II | 2002-09-23 |
| K020581 | COLOSHIELD COLONOSCOPY DRAPE MODEL E2000 | Medical Concepts Development, Inc. | KKX | Class II | 2002-09-18 |
| K022744 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | Medical Device Services | HWE | Class I | 2002-09-18 |
| K022444 | POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA | Wrp Asia Pacific Sdn. Bhd. | KGO | Class I | 2002-09-17 |
| K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE | ETHICON, Inc. | GAM | Class II | 2002-09-13 |
| K021975 | LASERSYSTEM BEAUTYSTAR 532 | Asclepion-Meditec AG | GEX | Class II | 2002-09-13 |
| K021946 | CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM | Cell Robotics, Inc. | GEX | Class II | 2002-09-11 |
| K022051 | SOUNDVASER SYSTEM | Sound Surgical Technologies, LLC | QPB | Class II | 2002-09-11 |
| K022104 | DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ | Daavlin Distributing Co. | FTC | Class II | 2002-09-10 |
| K022664 | PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. | Arc Medical Supplies (Beijing) Co, Ltd. | GAM | Class II | 2002-09-10 |
| K022782 | DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL | W. L. Gore & Associates, Inc. | FTL | Class II | 2002-09-10 |
| K021931 | ENDOSCOPIC FIBEROPTIC CABLE | Gulf Medical Fiberoptics | HBI | Class II | 2002-09-06 |
| K022442 | POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS) | Wrp Asia Pacific Sdn. Bhd. | KGO | Class I | 2002-09-05 |
| K021848 | CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160 | Clarus Medical, LLC | GEX | Class II | 2002-09-03 |
| K022569 | PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS | Medical Bio Care Sweden AB | GEX | Class II | 2002-08-29 |
| K022568 | PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR | Medical Bio Care Sweden AB | GEX | Class II | 2002-08-29 |
| K022718 | VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002 | Guidant Corporation, Cardiac Surgery | GEI | Class II | 2002-08-28 |
| K021804 | PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM | Medtronic Vascular | GEI | Class II | 2002-08-28 |
| K021834 | SUTURE FIXATION DEVICE; MESH FIXATION DEVICE | Mle, Inc. | GAW | Class II | 2002-08-28 |
| K021777 | GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | Gyrus Ent LLC | GEI | Class II | 2002-08-26 |
| K022350 | BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 | C.R. Bard, Inc. | FTL | Class II | 2002-08-23 |
| K021762 | BCLEAR | Lumenis, Inc. | FTC | Class II | 2002-08-23 |
| K022044 | SURGISIS STAPLE LINE REINFORCEMENT | Cook Biotech, Inc. | OXE | Class II | 2002-08-23 |
| K022544 | DORNIER MEDILAS H LASER FIBER CABLES | Dornier Medtech America, Inc. | GEX | Class II | 2002-08-21 |
| K022410 | SAPH-LOOP LIGATING LOOP | Genzyme Biosurgery | GAT | Class II | 2002-08-20 |
| K021696 | 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 | Ophthalmed, LLC | GEX | Class II | 2002-08-20 |
| K021686 | LASER FIBER GF500 | W.O.M. World of Medicine AG | GEX | Class II | 2002-08-20 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.