Review Panel
General, Plastic Surgery FDA 510(k) Clearances & Devices
- Cleared Devices
- 16,323
- Product Codes (page)
- 41
- Latest Decision
- 1986-04-14
Clearances · page 141 of 164
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K861076 | RESIDENTIAL TANNING UNIT | Sunmaker, Inc. | FTC | Class II | 1986-04-14 |
| K861138 | MASH DERMATOME | Mecron Medical Products, Inc. | GFD | Class I | 1986-04-14 |
| K860357 | HGM, INC. LASERCATH (STERILE) | Hgm, Inc. | LNK | Class II | 1986-04-07 |
| K860979 | DONALDSON NATURAL EYEPATCH | Keeler Instruments, Inc. | HMP | Class I | 1986-04-04 |
| K860936 | ABSORBENT, FIBER, OPERATING ROOM TOWELS | Ulti-Med Intl., Inc. | KKX | Class II | 1986-04-04 |
| K854833 | MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI | Meditec, Inc. | GEX | Class II | 1986-04-04 |
| K861050 | BIOPSY ADAPTER H4222W | General Electric Co. | GDF | Class I | 1986-04-02 |
| K860370 | SAFE SUN 700 HOME TANNING UNIT | Safe Sun Corporation of America, Inc. | FTC | Class II | 1986-03-28 |
| K860930 | ULTRASUN 2500 SUNTANNING UNIT | Medical Device Consultants, Inc. | FTC | Class II | 1986-03-28 |
| K860925 | DERMASPANDERE | Mri Ventures, Inc. | GFD | Class I | 1986-03-28 |
| K860856 | SILGMANN SOLARIUM SUN-MOBIL MODEL 0918 | Solarium Tanning Hut | FTC | Class II | 1986-03-28 |
| K860859 | UVA SUN SYSTEMS | Bremi | FTC | Class II | 1986-03-28 |
| K860931 | ULTRASUN 3000 AND 5000 SUNTANNING UNIT | Medical Device Consultants, Inc. | FTC | Class II | 1986-03-28 |
| K854386 | MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM | Directed Energy, Inc. | GEX | Class II | 1986-03-28 |
| K860929 | ULTRASUN 4000 FT & 15000-8 SUNTANNING UNIT | Medical Device Consultants, Inc. | FTC | Class II | 1986-03-28 |
| K860932 | ULTRASUN 1000 & 2000 SUNTANNING UNIT | Medical Device Consultants, Inc. | FTC | Class II | 1986-03-28 |
| K860739 | CHICK SURIGICAL LIGHT | Professional Medical Products, Inc. | FSY | Class II | 1986-03-28 |
| K860904 | VIDEO PRINTER, MODEL 3200 | Medline Industries, Inc. | KQM | Class I | 1986-03-28 |
| K860687 | BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768 | Birtcher Corp. | GEI | Class II | 1986-03-24 |
| K860912 | PS2 BRAND MAMMAPLASTY | Professional Services For Surgeons, Ltd. | FTY | Class I | 1986-03-24 |
| K860718 | ELECTROSURGERY PENCIL, MODEL 767 | Birtcher Corp. | GEI | Class II | 1986-03-24 |
| K855246 | AURORA M MEDICAL DYE LASER | Cooper Lasersonics, Inc. | GEX | Class II | 1986-03-21 |
| K850960 | NON-ABSORBENT DRAPES & ABSORBENT TOWELS | Excel Health Care Products | KKX | Class II | 1986-03-15 |
| K860496 | MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY | Xanar, Inc. | LNK | Class II | 1986-03-14 |
| K854740 | PRIMADERM | Absorbent Cotton Co., Inc. | NAD | Class I | 1986-03-14 |
| K860503 | THE POREX RETRACTOR TABLE | Porex Medical | FSE | Class I | 1986-03-13 |
| K860446 | C ARM SURGICAL TABLE | Medi-Mech, Inc. | FWZ | Class I | 1986-03-10 |
| K860534 | BILE ENDOPROSTHESIS SET | Angiomed U.S., Inc. | GBZ | Class I | 1986-03-10 |
| K860566 | NORDIC SUN 24 LAMP TANNING BED | Nordic Sun Corporation of America | FTC | Class II | 1986-03-05 |
| K860509 | SUNBED/CANOPY, MODELS GTI 24N,30R,30RE & 37RE | Ecomatic GmbH, Frankfurt, F.R.G. | FTC | Class II | 1986-03-05 |
| K860567 | NORDIC SUN HOME TANNING UNIT | Nordic Sun Corporation of America | FTC | Class II | 1986-03-05 |
| K855216 | 3M ARTHROSCOPIC SURGICAL SYSTEM | 3M Company | HWE | Class I | 1986-03-04 |
| K860582 | TBI NEEDLE | Hobbs Medical, Inc. | GAA | Class I | 1986-03-04 |
| K860160 | OPERATING ROOM TRAY | Medical Design Concepts, Inc. | FSM | Class I | 1986-02-27 |
| K855100 | S.L.T. CONTACT LASER SYSTEM | Surgical Laser Technologies, Inc. | LNK | Class II | 1986-02-26 |
| K860463 | SINGLE AND DUAL TOURNIQUET CUFF | Aspen Laboratories, Inc. | KCY | Class I | 1986-02-25 |
| K855119 | S.L.T. CONTACT LASER | Surgical Laser Technologies, Inc. | LNK | Class II | 1986-02-24 |
| K860489 | EUROTAN BY AYK | Eurotan Intl. | FTC | Class II | 1986-02-24 |
| K860326 | TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT | Deroyal Industries, Inc. | KKX | Class II | 1986-02-21 |
| K853901 | ENDO-LASE CD 40 FOR DERMATOLOGY | Endo Lase, Inc. | GEX | Class II | 1986-02-19 |
| K860447 | STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400 | Standard Textile Co., Inc. | KKX | Class II | 1986-02-19 |
| K860519 | RELIANCE MODEL 200 PODIATRY CHAIR | F. & F. Koenigkramer | LGX | Class I | 1986-02-19 |
| K855078 | ANGIO MED DISPOSABLE PRESSURE CONNECTORS | Angiomed U.S., Inc. | KGZ | Class I | 1986-02-19 |
| K860248 | 100% COTTON ABSORBENT TOWEL | Devon Industries, Inc. | KKX | Class II | 1986-02-19 |
| K860236 | PHAKOSYSTEMS CT-100 CAUTERY MODULE | Phakosystems, Inc. | GEI | Class II | 1986-02-19 |
| K853877 | ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY | Endo Lase, Inc. | GEX | Class II | 1986-02-19 |
| K860198 | MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING | Mottek Intl. Corp. | FTC | Class II | 1986-02-18 |
| K854750 | TOP SUN | Werner Schott Elektrogerate | FTC | Class II | 1986-02-14 |
| K854613 | SURGICAL DRAPES, OPHTHALMIN | Charles Atkins & Co. | HMT | Class II | 1986-02-13 |
| K860030 | SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID | Surgidyne, Inc. | BTA | Class II | 1986-02-12 |
| K860347 | SUNLAMP MODELS 24N, 30R, 30RE, 37RE | Gti, Inc. | FTC | Class II | 1986-02-12 |
| K855162 | ULTRAVIOLET SUN TANNING UNIT KETTLER HOLIDAY SOLAR | Mottek Intl. Corp. | FTC | Class II | 1986-02-12 |
| K860144 | SUM TAN VI | Nae, Inc. | FTC | Class II | 1986-02-12 |
| K854844 | LS1000 SURGICAL ASPIRATOR II | Engineering, Inc. | BTA | Class II | 1986-02-12 |
| K854669 | S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER | Surgical Laser Technologies, Inc. | LNK | Class II | 1986-02-11 |
| K854812 | NELSON-JUNG PLEURAL CATH | Research Medical, Inc. | GBW | Class I | 1986-02-11 |
| K854987 | INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM | Richard Wolf Medical Instruments Corp. | HWE | Class I | 1986-02-11 |
| K854472 | PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG | Minnesota Laser Corp. | GEX | Class II | 1986-02-11 |
| K860177 | ALLEN UNIVERSAL STIRRUP | Edgewater Medical Equipment Systems | BWN | Class I | 1986-02-11 |
| K854469 | PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG | Minnesota Laser Corp. | GEX | Class II | 1986-02-11 |
| K855203 | GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD | Miles Laboratories, Inc. | FMK | Class II | 1986-02-11 |
| K854387 | MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM | Directed Energy, Inc. | GEX | Class II | 1986-02-07 |
| K854399 | MODEL 20-B CO2 LASER SYSTEM | Directed Energy, Inc. | GEX | Class II | 1986-02-07 |
| K853627 | CODMAN LASER RODS | Codman & Shurtleff, Inc. | GEX | Class II | 1986-02-07 |
| K860173 | VIS-2000 VIDEO SYSTEM | Vistek Corp. | FWG | Class I | 1986-02-07 |
| K854134 | FIBEROPTIC COLLIMATING HANDPIECE | Dawn Laser Technology, Inc. | GEX | Class II | 1986-02-07 |
| K854398 | MODEL CO2 LASER SYSTEM 8B | Directed Energy, Inc. | GEX | Class II | 1986-02-07 |
| K853626 | CODMAN LASER BACKSTOP | Codman & Shurtleff, Inc. | GEX | Class II | 1986-02-07 |
| K860056 | BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR) | Berkowits School of Electrolysis, Inc. | KCW | Class I | 1986-02-05 |
| K855144 | TOURIQUET KIT WITH SNARE | Dlp, Inc. | GDJ | Class I | 1986-02-05 |
| K860152 | MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY | Endo Lase, Inc. | LNK | Class II | 1986-02-05 |
| K860063 | ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM | Laser Media | LNK | Class II | 1986-02-05 |
| K854587 | STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE | Storz Instrument Co. | HBI | Class II | 1986-02-04 |
| K860117 | KRYPTOSOL (SUN LAMP) | Trademark Imports | FTC | Class II | 1986-01-30 |
| K854932 | ECUMOL ULTRAVIOLET FACE TANNING UNITS | Mottek Intl. Corp. | FTC | Class II | 1986-01-30 |
| K854707 | SUNTAINNING BOOTH | David Connell | FTC | Class II | 1986-01-30 |
| K854594 | PHOENIX U.V.A. SUNTAN BEDS | Phoenix U.V.A. , Ltd. | FTC | Class II | 1986-01-30 |
| K855104 | ANGIOMED SKIN FASCIA KNIFE | Angiomed U.S., Inc. | GES | Class I | 1986-01-24 |
| K860095 | DIGIKIT NONPNEUMATIC TOURNIQUET | Orthofab, Inc. | KCY | Class I | 1986-01-24 |
| K855141 | ANGIOMED FINE NEEDLES AND NEEDLE SET | Angiomed U.S., Inc. | GAA | Class I | 1986-01-24 |
| K853620 | MODEL XA-50 - CO2 SURGICAL LASER | Xanar, Inc. | GEX | Class II | 1986-01-24 |
| K854916 | PILLING HEMOSTATIC CLIP APPLIER FORCEPS | Pilling Co. | GEN | Class I | 1986-01-24 |
| K854907 | PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) | Angiomed U.S., Inc. | GBO | Class I | 1986-01-24 |
| K854909 | PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS | Angiomed U.S., Inc. | GBO | Class I | 1986-01-24 |
| K860088 | PL EXAM LIGHT | Burton Medical Products Corp. | FTD | Class II | 1986-01-24 |
| K854988 | KY-M280U SURGICAL CAMERA | Us Jvc Corp. | FWC | Class I | 1986-01-24 |
| K855039 | MEDIFLEX INJECTION CAP | Mediflex Intl. | GCE | Class I | 1986-01-24 |
| K854906 | PERCUTANEOUS NEPHROSTOMY SETS (OTTO) | Angiomed U.S., Inc. | GBO | Class I | 1986-01-24 |
| K854109 | ELECTROSURGICAL DEVICES, 26-0330,26-335,340 & 0345 | Cameron-Miller, Inc. | GEI | Class II | 1986-01-24 |
| K854767 | LM 1000 | Leisegang Medical, Inc. | GEH | Class II | 1986-01-24 |
| K854905 | PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) | Angiomed U.S., Inc. | GBO | Class I | 1986-01-24 |
| K854922 | AMSCO POLARIS SL | Amsco Co. | FSY | Class II | 1986-01-24 |
| K853972 | CAMERON-MILLER MODEL 80-2701, BIPOLAR COAGULATOR | Cameron-Miller, Inc. | GEI | Class II | 1986-01-24 |
| K855132 | SHAVE PREP TRAY | Dynarex Corp. | MDM | Class I | 1986-01-24 |
| K860020 | MINOR SURGERY LIGHT MODEL 2112 | Adel Medical , Ltd. | FSS | Class II | 1986-01-24 |
| K855020 | MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930 | Medline Industries, Inc. | FWB | Class I | 1986-01-24 |
| K854911 | PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) | Angiomed U.S., Inc. | GBO | Class I | 1986-01-24 |
| K855197 | FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM | Laser Media | LNK | Class II | 1986-01-21 |
| K855047 | AUTO SUTURE TITANIUM SURGICAL STAPLES | United States Surgical, A Division of Tyco Healthc | GDW | Class II | 1986-01-14 |
| K854850 | FALKON STRETCH-STERILE | G.B.F. Industries, Inc. | NAD | Class I | 1986-01-13 |
16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.