meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
38
Latest Decision
2010-12-16

Clearances · page 53 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K102755 CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER Biolitec, Inc. GEX Class II 2010-12-16
K102029 PEAK PULSAR II GENERATOR MODEL PS100-102 Peak Surgical, Inc. GEI Class II 2010-12-16
K101413 EUROMI EVA SP6 Euromi S.A QPB Class II 2010-12-16
K102796 ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT AngioDynamics, Inc. GEX Class II 2010-12-15
K102956 V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2010-12-15
K100780 VITAL SUTURES, SUTUREX, CIRUGIA PERUANA Unilene Sac NEW Class II 2010-12-14
K102749 QUANTA CYBER TM 150W Quanta System Spa GEX Class II 2010-12-10
K101520 ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH Ethicon Endo-Surgery, Inc. GEI Class II 2010-12-10
K093565 PLEURAFLOW CATHETER SYSTEM Clear Catheter Systems OTK Class II 2010-12-03
K102768 SECRMARK BIOPSY SITE MARKING SYSTEM Hologic, Inc. NEU Class II 2010-12-02
K102639 SL3 Discus Dental, LLC GEX Class II 2010-12-01
K100487 EQUINOX CO2 LASER SYSTEM Eclipsemed Global, Inc. ONG Class II 2010-11-29
K102360 ICESENCE 3 IceCure Medical , Ltd. GEH Class II 2010-11-29
K100586 VENUS FREEZE SYSTEM Venus Concept , Ltd. GEI Class II 2010-11-29
K100199 ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT AngioDynamics, Inc. GEX Class II 2010-11-26
K100628 PLASMALUXLS Daavlin Distributing Co. ONE Class II 2010-11-24
K101534 CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM Conmedcorp GEI Class II 2010-11-24
K103269 PATCHASSIST LARGE Polytouch Medical, Ltd. ORQ Class II 2010-11-23
K102339 CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE Conmed Linvatec GAT Class II 2010-11-23
K102791 EASYSUITE SURGICAL LIGHT CONTROL (ESLC) Image Stream Medical, Inc. FTA Class II 2010-11-23
K101163 BIOGEL ORTHOPRO INDICATOR UNDERGLOVE Molnlycke Health Care USA KGO Class I 2010-11-23
K101817 LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N Fotona D.D. GEX Class II 2010-11-22
K103263 ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY Covidien, Formerly US Surgical A Divison of Tyco H GDW Class II 2010-11-22
K102114 MEDRANGE ELECTROSURGICAL GENERATOR Medrange Corporation GEI Class II 2010-11-22
K103118 REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR Hoya Photonics, Inc. GEX Class II 2010-11-19
K102923 BARRIER N95 PARTICULATE RESPIRATOR Molnlycke Health Care MSH Class II 2010-11-19
K094016 NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H Hinson and Hale Medical Technologies, Inc. KKX Class II 2010-11-19
K102669 DIODE LASER THERAPY SYSTEM China Daheng Group, Inc. GEX Class II 2010-11-17
K103282 LAPAROSCOPIC DISSECTOR Applied Medical Resources Corp. GEI Class II 2010-11-16
K102626 VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 Vega Technologies, Inc. JCX Class II 2010-11-12
K101174 ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 AtriCure, Inc. OCL Class II 2010-11-12
K103052 V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE Covidien, LLC GAT Class II 2010-11-10
K100590 EDGE CO2 LASER SYSTEM Jm System Co., Ltd. ONG Class II 2010-11-10
K103184 SILK'N FLASH N GO Home Skinovations , Ltd. OHT Class II 2010-11-10
K101321 EMATRIX CO2 Syneron Medical, Ltd. GEX Class II 2010-11-09
K102666 KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM Kimberly-Clark Corp. KKX Class II 2010-11-09
K101382 DPL NUVE Led Technologies, LLC OHS Class II 2010-11-09
K101519 PARIETEX PLUG AND PATCH Sofradim Production FTL Class II 2010-11-05
K102500 STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING Cardinal Health, Inc. KGO Class I 2010-11-04
K102372 OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB Jiangmen City Xinhui Baisheng Medical Equipment CO GEI Class II 2010-11-03
K102983 VASCUCLEAR PRECISION BIPOLAR Sorin Group USA, Inc. GEI Class II 2010-11-01
K101961 TIGERPAW SYSTEM Laax, Inc. GDW Class II 2010-10-29
K101712 ENDOVASCULAR LAER VEIN SYSTEM KIT Biolitec, Inc. GEX Class II 2010-10-27
K103010 STRYKER PATIENT SPECIFIC POLYMER IMPLANT Howmedica Osteonics Corp., Dba Stryker Orthopaedics KKY Class II 2010-10-26
K102758 TRULIGHT 5520 AND TRULIGHT 5320 Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg FSY Class II 2010-10-26
K100744 CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 Neuwave Medical, Inc. NEY Class II 2010-10-22
K101145 SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 Medipurpose Pte. , Ltd. FMK Class II 2010-10-21
K101006 WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 Alcon Research, Ltd. GEX Class II 2010-10-21
K102916 G-CATH TISSUE ANCHOR DELIVERY CATHETER Usgi Medical GAT Class II 2010-10-20
K101417 BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 Medipurpose Pte. , Ltd. FMK Class II 2010-10-19
K093545 PINPOINTE FOOTLASER MODEL 6W, 30W, 100W Incisive, Inc. (Formerly Named Incisive, LLC) GEX Class II 2010-10-15
K101811 PROTEGRITY SMT LATEX SURGICALGLOVES Cardinal Health, Inc. KGO Class I 2010-10-15
K093547 PINPOINTE FOOTLASER Pinpointe USA, Inc. PDZ Class II 2010-10-15
K102325 IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) Covidien, LLC, Formerly Registered AS Tyco Healthca GDW Class II 2010-10-13
K100593 SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME Lsi Solutions, Inc. GAW Class II 2010-10-13
K102608 SECURMARK BIOPSY SITE MARKING SYSTEM Suros Surgical Systems, Inc. A Hologic Company NEU Class II 2010-10-08
K102632 ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER Ethicon Endo-Surgery, Inc. GDW Class II 2010-10-07
K102006 CRYOMEGA Stc Consulting, LLC GEH Class II 2010-10-06
K102092 PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES Prestige Ameritech MSH Class II 2010-10-06
K100991 IMC SURGICAL DRAPE International Medsurg Connection KKX Class II 2010-10-05
K101598 EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) Exact Medical Manufacturing, Inc. KKX Class II 2010-10-04
K102477 NO!NO! SKIN Radiancy (Israel) , Ltd. OLP Class II 2010-10-04
K101537 AIM 200, MAJOR SURGICAL LIGHT Burton Medical Products Corp. FSY Class II 2010-09-30
K100114 FAT CONCENTRATION SYSTEM Biomet, Inc. MUU Class II 2010-09-29
K101825 CRYOBALLOON ABLATION SYSTEM C2 Therapeutics GEH Class II 2010-09-29
K102036 DOCTOR SURGERY DIODE LASERS FAMILY Lambda S.P.A. GEX Class II 2010-09-28
K102716 MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS Alma Lasers, Inc. GEX Class II 2010-09-28
K100971 ATEK SURGICAL GOWNS Hangzhou Atek Medical & Textile Co., Ltd. FYA Class II 2010-09-27
K102266 ISOLED AC-POWERED LED HEADLIGHT SYSTEM Isolux, LLC FST Class II 2010-09-24
K101601 AFFIRM DO DIODE LASER Cynosure, Inc. GEX Class II 2010-09-23
K101573 ACCUSCULPT II LASER SYSTEM Lutronic Corporation GEX Class II 2010-09-23
K101688 EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 Exact Medical Manufacturing, Inc. KKX Class II 2010-09-20
K092734 E-LIGHT LINE Espansione Marketing S.P.A GEX Class II 2010-09-20
K101689 EMM EQUIPMENT COVER-POLYTHYLENE Exact Medical Manufacturing, Inc. KKX Class II 2010-09-20
K091467 BABY QUASAR Silver Bay, LLC ONE Class II 2010-09-17
K101366 I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) Chromogenex Technologies, Ltd. NUV Class II 2010-09-17
K100787 RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT Smith & Nephew, Inc. FTL Class II 2010-09-17
K101555 CO2 LASER SYSTEM Advanced Technology Laser Co., Ltd. GEX Class II 2010-09-17
K100657 V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U Kci USA, Inc. (Kinetic Concepts, Inc.) OMP Class II 2010-09-17
K101587 PROPATCH SOFT TISSUE REPAIR MATRIX Cryolife, Inc. FTM Class II 2010-09-16
K102291 COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY Covidien GDW Class II 2010-09-15
K100726 CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM Biolitec, Inc. GEX Class II 2010-09-15
K101496 CABLECAP MODEL: WLF, STZ, ACM Sensormed FST Class II 2010-09-14
K101783 COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE New Star Lasers, Inc. GEX Class II 2010-09-13
K102173 MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 Moldex/Metric, Inc. MSH Class II 2010-09-13
K093901 SURGICAL FACE MASK Epard Protective Products, Ltd. FXX Class II 2010-09-10
K094049 STLASE DIODE LASER Dental Photonics, Inc. GEX Class II 2010-09-10
K101490 FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US Thermage, Inc. ONG Class II 2010-09-08
K102368 NON-ABLATIVE WRINKLE TREATMENT HANDPIECE Ellman Int'L, Inc. GEI Class II 2010-09-07
K091125 CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 Verilux ONE Class II 2010-09-03
K101593 EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL Exact Medical Manufacturing, Inc. FYA Class II 2010-09-03
K101506 LUX1540, LUX1440 & LUX2940 LASER HANDPIECES Palomar Medical Technologies, Inc. ONG Class II 2010-09-01
K101287 TEPHAFLEX COMPOSITE MESH Tepha, Inc. OWT Class II 2010-08-30
K093963 QUASAR BLUE LIGHT THERAPY SYSTEM Silver Bay, LLC OLP Class II 2010-08-27
K102119 SUR-G GLOV AND MAXITEX Terang Nusa Sdn Bhd KGO Class I 2010-08-27
K100390 SURGIMAX/ SURGIMAX PLUS Elliquence, LLC GEI Class II 2010-08-25
DEN090002 ZELTIQ AESTHETICS DERMAL COOLING DEVICE Zeltiq Aesthetics OOK Class II 2010-08-24
DEN090008 ERCHONIA ML SCANNER (MLS) Erchonia Medical OLI Class II 2010-08-24
K093622 AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 Encision, Inc. GEI Class II 2010-08-20
K101152 NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 Focus Medical, LLC GEX Class II 2010-08-18

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.