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 25 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K920597 | HANDI-LASE CO2 SURGICAL LASER INSTRUMENT | Sorenson Laboratories, Inc. | 1992-06-04 | Traditional | PDF ↗ |
| K920821 | UNIMAX MODEL 2000 COLOR-CORRECTED MICROSPOT CO2 | Reliant Laser Corp. | 1992-05-21 | Traditional | PDF ↗ |
| K920004 | PBI MULTILASE D COPPER VAPOR LASER | Wm.I.Kern & Co., Inc. | 1992-05-14 | Traditional | PDF ↗ |
| K921596 | SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE | Sharplan Lasers, Inc. | 1992-05-13 | Traditional | PDF ↗ |
| K914991 | VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS | Coherent Medical Group | 1992-05-06 | Traditional | PDF ↗ |
| K920934 | HALOCATH LASER CATHETERS | Trimedyne, Inc. | 1992-04-29 | Traditional | PDF ↗ |
| K920589 | ANGLED DELIVERY DEVICE | Laserscope | 1992-04-29 | Traditional | PDF ↗ |
| K910422 | MODEL RD-1200 RUBY LASER SYSTEM | Spectrum Medical Technologies, Inc. | 1992-04-21 | Traditional | PDF ↗ |
| K910152 | ORION | Pfizer Laser Systems | 1992-04-15 | Traditional | PDF ↗ |
| K920120 | ND:YAG SURGICAL LASER | Carl Zeiss, Inc. | 1992-04-10 | Traditional | PDF ↗ |
| K920584 | SCULPTURED ENDOSTAT | Laserscope | 1992-04-10 | Traditional | PDF ↗ |
| K915656 | CARBON DIOXIDE CO2 LASER | Ion Laser Technology | 1992-04-10 | Traditional | PDF ↗ |
| K914197 | ALLOY SCALPEL HANDPIECES | L.A.S.E.R., Inc. | 1992-04-10 | Traditional | PDF ↗ |
| K914679 | PRODIGY ND:YAG SURGICAL LASER SYSTEM | Xintec Corporation | 1992-04-07 | Traditional | PDF ↗ |
| K920529 | ZEISS MULTIYAG LASER | Carl Zeiss, Inc. | 1992-04-02 | Traditional | PDF ↗ |
| K915169 | EXCEL MODEL XLT-TWO HOLMIUM:YAG LASER SYSTEM | Excel Tech. , Ltd. | 1992-04-02 | Traditional | PDF ↗ |
| K915117 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM | Trimedyne, Inc. | 1992-04-02 | Traditional | PDF ↗ |
| K920632 | SIDE FIRING FIBERS | Trimedyne, Inc. | 1992-04-02 | Traditional | PDF ↗ |
| K920625 | LATERALASE | Trimedyne, Inc. | 1992-04-02 | Traditional | PDF ↗ |
| K914518 | KTP/YAG AND KTP/YAG PLUS | Laserscope | 1992-04-02 | Traditional | PDF ↗ |
| K914827 | LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION | Laser Photonics, Inc. | 1992-03-27 | Traditional | PDF ↗ |
| K915583 | CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR. | Heraeus Lasersonics, Inc. | 1992-03-27 | Traditional | PDF ↗ |
| K920553 | MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER | Myriad Lase, Inc. | 1992-03-26 | Traditional | PDF ↗ |
| K915840 | ZEISS MULTIYAG LASER | Carl Zeiss, Inc. | 1992-03-23 | Traditional | PDF ↗ |
| K920106 | ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS. | Sunrise Technologies, Inc. | 1992-03-13 | Traditional | PDF ↗ |
| K920107 | ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR | Sunrise Technologies, Inc. | 1992-03-13 | Traditional | PDF ↗ |
| K913839 | OPTICA 25 ND:YAG DENTAL LASER SYSTEM | Xintec Corporation | 1992-03-13 | Traditional | PDF ↗ |
| K915561 | ZEISS MULTIYAG LASER | Carl Zeiss, Inc. | 1992-03-11 | Traditional | PDF ↗ |
| K914455 | SHARPLAN MODELS 100 SERIES C02 LASERS/ACCESSORIES | Sharplan Lasers, Inc. | 1992-03-11 | Traditional | PDF ↗ |
| K915497 | CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM | Continuum Biomedical, Inc. | 1992-03-06 | Traditional | PDF ↗ |
| K915085 | DL100 C02 SURGICAL LASER SYSTEM | Mnlase, Inc. | 1992-02-28 | Traditional | PDF ↗ |
| K912618 | LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY | Heraeus Lasersonics, Inc. | 1992-02-27 | Traditional | PDF ↗ |
| K914849 | EXCEL MODEL XLT-ONE ND:YAG LASER SYSTEM | Excel Tech. , Ltd. | 1992-02-25 | Traditional | PDF ↗ |
| K915354 | LATERALASE | Trimedyne, Inc. | 1992-02-24 | Traditional | PDF ↗ |
| K912879 | MODEL SLASE 210 HOLMIUM (THC:YAG) LASER SYSTEM | Sunrise Technologies, Inc. | 1992-02-21 | Traditional | PDF ↗ |
| K913290 | MULTILASE 2100 A | Teknomed, Inc. | 1992-02-21 | Traditional | PDF ↗ |
| K915768 | SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030 | Surgical Laser Products, Inc. | 1992-02-11 | Traditional | PDF ↗ |
| K915370 | COPPER VAPOR LASER SYSTEM | Metatech Corp. | 1992-02-07 | Traditional | PDF ↗ |
| K915000 | ACU-GUARD | Acuderm, Inc. | 1992-01-27 | Traditional | PDF ↗ |
| K915223 | METAL ENCLOSED SIDE FIRING FIBERS | Trimedyne, Inc. | 1992-01-23 | Traditional | PDF ↗ |
| K913256 | DERMA-LASE RUBY LASER - MODEL DLR-1 | Derma-Lase Co. | 1992-01-22 | Traditional | PDF ↗ |
| K912813 | SIRIUS | Pfizer Laser Systems | 1991-12-31 | Traditional | PDF ↗ |
| K910823 | PERCUDISC(TM) SYSTEM | Percudisc, Inc. | 1991-12-30 | Traditional | PDF ↗ |
| K914396 | SURGI LIGHT NON-CONTACT FIBERS | Lifestream Int'L, Inc. | 1991-12-23 | Traditional | PDF ↗ |
| K914952 | MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM | Trimedyne, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K913606 | CHRYS XX CO2 SURGICAL LASER SYSTEM | Jamar Medical Systems | 1991-12-19 | Traditional | PDF ↗ |
| K914175 | MICROSURGE LASER FIBER WITH SMA CONNECTOR | Microsurge, Inc. | 1991-12-17 | Traditional | PDF ↗ |
| K915352 | LASER FIBEROPTIC DELIVERY SYSTEM | Sunrise Technologies, Inc. | 1991-12-17 | Traditional | PDF ↗ |
| K914726 | ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED | Ion Laser Technology | 1991-12-17 | Traditional | PDF ↗ |
| K913887 | C02 LASER WAVEGUIDE | Heraeus Lasersonics, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K914089 | SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG | Sharplan Lasers, Inc. | 1991-12-06 | Traditional | PDF ↗ |
| K914423 | OPTIFIBER | Minimal Invasive Therapy and Diagnostics, Inc. | 1991-12-02 | Traditional | PDF ↗ |
| K913758 | KTP/532 AND KTP/YAG | Laserscope | 1991-11-20 | Traditional | PDF ↗ |
| K913430 | IRIS OCULIGHT(R) SLX | Iriderm Div. | 1991-11-15 | Traditional | PDF ↗ |
| K914677 | MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG | Sunrise Technologies, Inc. | 1991-11-08 | Traditional | PDF ↗ |
| K911926 | POLARIS, OPHTHALMOLOGY | Pfizer Laser Systems | 1991-11-07 | Traditional | PDF ↗ |
| K914568 | MODEL DLASER 1000 ND;YAG LASER SYSTEM | Sunrise Technologies, Inc. | 1991-11-07 | Traditional | PDF ↗ |
| K910530 | CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY | Heraeus Lasersonics, Inc. | 1991-10-31 | Traditional | PDF ↗ |
| K912987 | CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE | Douglas James Donaldson Compliance Services | 1991-10-28 | Traditional | PDF ↗ |
| K913465 | NIDEK MODELS AC-2100 & 2200 | Nidek, Inc. | 1991-10-21 | Traditional | PDF ↗ |
| K913569 | COMPAC A, ELITE A, ELITE A PLUS, SURGICA A | Hgm Medical Laser Systems, Inc. | 1991-10-17 | Traditional | PDF ↗ |
| K913191 | DORNIER LASER LITHOTRIPTER IMPACT | Dornier Medtech America, Inc. | 1991-10-16 | Traditional | PDF ↗ |
| K912063 | POLARIS, ORAL INDICATION | Pfizer Laser Systems | 1991-10-16 | Traditional | PDF ↗ |
| K912703 | OPTICA 60 ND;YAG SURGICAL LASER SYSTEM | Xintec Corporation | 1991-10-11 | Traditional | PDF ↗ |
| K911925 | POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GU | Pfizer Laser Systems | 1991-10-11 | Traditional | PDF ↗ |
| K910341 | POLARIS | Pfizer Laser Systems | 1991-10-11 | Traditional | PDF ↗ |
| K913109 | LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK | Trimedyne, Inc. | 1991-10-08 | Traditional | PDF ↗ |
| K913127 | COHERENT NOVUS 3000 ARGON PHOTOCOAGULATOR | Coherent Medical Group | 1991-10-08 | Traditional | PDF ↗ |
| K914104 | ENDOSTAT | Laserscope | 1991-09-27 | Traditional | PDF ↗ |
| K913918 | HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER | Heraeus Lasersonics, Inc. | 1991-09-25 | Traditional | PDF ↗ |
| K910037 | COHERENT HOLMIUM:YAG SURGICAL LASER | Coherent Medical Group | 1991-09-25 | Traditional | PDF ↗ |
| K910027 | CRYSTAL FOCUS EMERALD LASER SLT MCX 1.5 CONVEX PRO | Biovision, Inc. | 1991-09-25 | Traditional | PDF ↗ |
| K912793 | SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (CLS) | Surgical Laser Technologies, Inc. | 1991-09-18 | Traditional | PDF ↗ |
| K913564 | HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE | Heraeus Lasersonics, Inc. | 1991-09-16 | Traditional | PDF ↗ |
| K912628 | AIR ARGON ION LASERS VARIOUS MODELS | Hgm Medical Laser Systems, Inc. | 1991-09-13 | Traditional | PDF ↗ |
| K913513 | LATERALASE STERILE DISPOSABLE FIBER | Heraeus Lasersonics, Inc. | 1991-09-11 | Traditional | PDF ↗ |
| K913488 | STI CONTACT 200 FIBEROPTIC DELIVERY SYSTEM | Sunrise Technologies, Inc. | 1991-09-10 | Traditional | PDF ↗ |
| K913037 | SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS | Sharplan Lasers, Inc. | 1991-09-06 | Traditional | PDF ↗ |
| K912538 | KTP/YAG PLUS | Laserscope | 1991-09-06 | Traditional | PDF ↗ |
| K911457 | TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST | Trimedyne, Inc. | 1991-09-05 | Traditional | PDF ↗ |
| K912792 | SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER | Sharplan Lasers, Inc. | 1991-08-29 | Traditional | PDF ↗ |
| K912918 | IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER | Iriderm Div. | 1991-08-23 | Traditional | PDF ↗ |
| K912332 | MICROSURGE LASER FIBER HOLDER | Microsurge, Inc. | 1991-08-21 | Traditional | PDF ↗ |
| K912284 | BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF | Douglas James Donaldson Compliance Services | 1991-08-19 | Traditional | PDF ↗ |
| K910062 | 02-10,001 | Laser Engineering, Inc. | 1991-08-16 | Traditional | PDF ↗ |
| K911830 | LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER | Laserscope | 1991-08-14 | Traditional | PDF ↗ |
| K912029 | ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER | Coherent Medical Group | 1991-08-13 | Traditional | PDF ↗ |
| K911987 | LUXUS 132 ND: YAG SURGICAL LASER SYSTEM | Heraeus Lasersonics, Inc. | 1991-08-13 | Traditional | PDF ↗ |
| K910272 | HGM COMBINATION ND:YAG & SOLID STATE GREEN | Hgm Medical Laser Systems, Inc. | 1991-08-09 | Traditional | PDF ↗ |
| K905802 | CENTAURI/PEGASUS | Pfizer Laser Systems | 1991-07-19 | Traditional | PDF ↗ |
| K912438 | MODELS 5,8,20,20S ARGON ION LASERS | Hgm Medical Laser Systems, Inc. | 1991-07-17 | Traditional | PDF ↗ |
| K904632 | CENTAURI YAG LASER SYST, GYNECOLOGY | Pfizer Laser Systems | 1991-07-11 | Traditional | PDF ↗ |
| K911150 | SOREX SAFE-AIR | Sorex Medical | 1991-06-28 | Traditional | PDF ↗ |
| K895363 | BIOVISION EMERALD LASER PHOTOCOAGULATOR | F.I.T. of France | 1991-06-24 | Traditional | PDF ↗ |
| K910602 | HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY | Hgm Medical Laser Systems, Inc. | 1991-06-24 | Traditional | PDF ↗ |
| K903418 | LATERALASE TM | Trimedyne, Inc. | 1991-06-24 | Traditional | PDF ↗ |
| K904631 | CENTAURI YAG LASER SYST, NEUROSURGERY | Pfizer Laser Systems | 1991-06-18 | Traditional | PDF ↗ |
| K905737 | CENTAURI/PEGASUS | Pfizer Laser Systems | 1991-06-17 | Traditional | PDF ↗ |
| K911852 | COMPULSE CO2 SURGICAL LASER SYS. | Laser Engineering, Inc. | 1991-06-07 | Traditional | PDF ↗ |
| K911408 | CROSSFIRE LASER ASSISTED ASPIRATION CANNULA | Heraeus Lasersonics, Inc. | 1991-06-03 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.