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 28 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K890321 | SLT CONTACT LASER SYSTEM (ORTHOPEDICS) | Surgical Laser Technologies, Inc. | 1989-04-05 | Traditional | PDF ↗ |
| K890322 | SLT CONTACT LASER SYSTEM (ENT, HEAD & NECK SURG.) | Surgical Laser Technologies, Inc. | 1989-04-05 | Traditional | PDF ↗ |
| K890865 | HEXASCAN SCANNER HANDPIECE | Metatech Corp. | 1989-03-24 | Traditional | PDF ↗ |
| K891088 | MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE | Sharplan Lasers, Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K891126 | MICROLASE CO2 LASER MICROMANIPULATOR | Ximed Medical Systems | 1989-03-17 | Traditional | PDF ↗ |
| K891016 | SHARPLAN MODEL 2106 | Sharplan Lasers, Inc. | 1989-03-13 | Traditional | PDF ↗ |
| K890040 | MODIFIED LABELING & PACKAGING OF SHARPLAN 2100 | Sharplan Lasers, Inc. | 1989-02-14 | Traditional | PDF ↗ |
| K890279 | MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER | Trimedyne, Inc. | 1989-02-07 | Traditional | PDF ↗ |
| K890059 | SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749 | Sharplan Lasers, Inc. | 1989-02-06 | Traditional | PDF ↗ |
| K885291 | MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES | Pfizer Laser Systems | 1989-02-03 | Traditional | PDF ↗ |
| K890174 | SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION) | Surgical Laser Technologies, Inc. | 1989-01-26 | Traditional | PDF ↗ |
| K884182 | SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL | Surgilase, Inc. | 1989-01-24 | Traditional | PDF ↗ |
| K883379 | MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2 | Heraeus Lasersonics, Inc. | 1989-01-24 | Traditional | PDF ↗ |
| K885181 | (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 | Heraeus Lasersonics, Inc. | 1989-01-10 | Traditional | PDF ↗ |
| K884682 | LIVING TECHNOLOGY LASER CONTACT TIPS | Living Technology, Inc. | 1989-01-05 | Traditional | PDF ↗ |
| K884459 | LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE | Luxar Corp. | 1988-12-19 | Traditional | PDF ↗ |
| K883488 | CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. | Heraeus Lasersonics, Inc. | 1988-12-19 | Traditional | PDF ↗ |
| K884994 | SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP | Sharplan Lasers, Inc. | 1988-12-15 | Traditional | PDF ↗ |
| K884456 | STERILE DISPOSABLE ENDOCULAR PROBE | Biophysic Medical, Inc. | 1988-12-09 | Traditional | PDF ↗ |
| K884431 | HEXASCAN HANDPIECE FOR ARGON/DYE LASER | California Laboratories, Inc. | 1988-12-02 | Traditional | PDF ↗ |
| K884029 | KTP/532 SURGICAL LASER | Laserscope | 1988-11-25 | Traditional | PDF ↗ |
| K883738 | CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. | Directed Energy, Inc. | 1988-11-15 | Traditional | PDF ↗ |
| K883541 | METALASER VASCULASE | Metatech Corp. | 1988-11-04 | Traditional | PDF ↗ |
| K884060 | MEDITEC QL-15 ND:YAG LASER | Storz Ophthalmics, Inc. | 1988-11-04 | Traditional | PDF ↗ |
| K884204 | COHERENT EXCELITE CO2 AIR FIBER | Coherent Medical Lasers | 1988-11-03 | Traditional | PDF ↗ |
| K882952 | CO2 SURGICAL LASER SYSTEM MODEL #IR106 | Niic U.S.A., Inc. | 1988-11-02 | Traditional | PDF ↗ |
| K882951 | CO2 SURGICAL LASER SYSTEM MODEL #IR105 | Niic U.S.A., Inc. | 1988-11-02 | Traditional | PDF ↗ |
| K884311 | MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS | Surgilase, Inc. | 1988-10-27 | Traditional | PDF ↗ |
| K884313 | MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS | Surgilase, Inc. | 1988-10-27 | Traditional | PDF ↗ |
| K883642 | CODMAN NEUROLASE LASER SYSTEM | I.L. Med, Inc. | 1988-10-20 | Traditional | PDF ↗ |
| K884092 | SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80 | Surgilase, Inc. | 1988-10-13 | Traditional | PDF ↗ |
| K883089 | 4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02 | Heraeus Lasersonics, Inc. | 1988-09-28 | Traditional | PDF ↗ |
| K883563 | SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS | Sharplan Lasers, Inc. | 1988-09-27 | Traditional | PDF ↗ |
| K882926 | MODEL AU-1 ACCESSORY UNIT | Directed Energy, Inc. | 1988-09-09 | Traditional | PDF ↗ |
| K882734 | KTP/YAG(TM) SURGICAL LASER | Laserscope | 1988-09-09 | Traditional | PDF ↗ |
| K882365 | HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900 | Heraeus Lasersonics, Inc. | 1988-09-02 | Traditional | PDF ↗ |
| K882738 | L.P.I. LASER DELIVERY SYSTEM | Laser Photonics, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K882772 | LQ1106 OPHTHALMIC YAG LASER | Keeler Instruments, Inc. | 1988-08-26 | Traditional | PDF ↗ |
| K882942 | LASER MIXTURE | Swisco, Inc. | 1988-08-23 | Traditional | PDF ↗ |
| K882212 | SLT CONTACT LASER SYSTEM | Surgical Laser Technologies, Inc. | 1988-08-17 | Traditional | PDF ↗ |
| K882516 | THREE-COMPONENT MEDICAL LASER GAS MIXTURES | Matheson Gas Products, Inc. | 1988-08-03 | Traditional | PDF ↗ |
| K882208 | MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES | Linde Div. Union Carbide Corp. | 1988-08-03 | Traditional | PDF ↗ |
| K880816 | MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM | Niic U.S.A., Inc. | 1988-08-01 | Traditional | PDF ↗ |
| K881940 | MODEL 20 KY KRYPTON YELLOW LASER | Hgm Medical Laser Systems, Inc. | 1988-07-20 | Traditional | PDF ↗ |
| K871512 | SL-100 ND:YAG LASER FOR GYNECOLOGY USE | Medical Energy, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K881619 | 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER | Heraeus Lasersonics, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K882243 | SPTL-1 PULSED DYE LASER | Candela Laser Corp. | 1988-07-05 | Traditional | PDF ↗ |
| K881788 | KTP/532(TM) SURGICAL LASER | Laserscope | 1988-06-27 | Traditional | PDF ↗ |
| K882160 | COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR | Coherent Medical Lasers | 1988-06-22 | Traditional | PDF ↗ |
| K880061 | FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM | Abbott Laboratories | 1988-06-20 | Traditional | PDF ↗ |
| K882037 | SHARPLAN MEDILAS 4060 N | Sharplan Lasers, Inc. | 1988-06-20 | Traditional | PDF ↗ |
| K881587 | MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS | Laser Engineering, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K881583 | MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT | Laser Engineering, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K881582 | MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE | Laser Engineering, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K881952 | SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI. | Sharplan Lasers, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K881586 | MODEL MD-45 CO2 LASER FOR ENT APPLICATIONS | Laser Engineering, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K881585 | MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE | Laser Engineering, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K881581 | MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE | Laser Engineering, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K881584 | MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE | Laser Engineering, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K881953 | SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU | Sharplan Lasers, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K881588 | MODEL MD-25 LASER FOR SURGICAL USE | Laser Engineering, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K881580 | MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY | Laser Engineering, Inc. | 1988-06-03 | Traditional | PDF ↗ |
| K882180 | MODIFIED SHARPLAN MODEL 1020 CO2 LASER | Sharplan Lasers, Inc. | 1988-06-02 | Traditional | PDF ↗ |
| K881870 | SHARPLAN ND:YAG SURGICAL HAND APPLICATORS | Sharplan Lasers, Inc. | 1988-05-24 | Traditional | PDF ↗ |
| K881824 | LASER MICROMANIPULATOR | Pfizer Laser Systems | 1988-05-24 | Traditional | PDF ↗ |
| K881887 | SHARPLAN 719Y MICROSLAD(TM) | Sharplan Lasers, Inc. | 1988-05-13 | Traditional | PDF ↗ |
| K881848 | MODIFIED MODEL 2100 ND:YAG LASER | Sharplan Lasers, Inc. | 1988-05-11 | Traditional | PDF ↗ |
| K880908 | MODEL PC ARGON LASER | Hgm, Inc. | 1988-05-03 | Traditional | PDF ↗ |
| K880808 | ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU | Cooper Lasersonics, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K880809 | ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU | Cooper Lasersonics, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K880807 | ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU | Cooper Lasersonics, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K875338 | CHRYS(TM) MODEL MED-MAX | California Laboratories, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K880603 | COHERENT XA-40 CO2 SURGICAL LASER | Coherent Medical Group | 1988-03-11 | Traditional | PDF ↗ |
| K880216 | MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. | Directed Energy, Inc. | 1988-03-04 | Traditional | PDF ↗ |
| K875115 | INFRAGUIDE(TM) | Cooper Lasersonics, Inc. | 1988-02-26 | Traditional | PDF ↗ |
| K874948 | SUN MEDICAL SMOKE EVACUATOR SYSTEM | Sun Medical, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K874811 | MODEL 5202 MICROMANIPULATOR | Coherent Medical Group | 1988-02-05 | Traditional | PDF ↗ |
| K874648 | COHERENT XA-30/SP CO2 SURGICAL LASER | Coherent Medical Group | 1988-02-04 | Traditional | PDF ↗ |
| K873790 | MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY | Cooper Lasersonics, Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K871933 | MODEL 5050 SURGILASER FOR NEUROSURGERY USE | Lasermatic, Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K873443 | ULTRASPOT MICROMANIPULATOR | Cooper Lasersonics, Inc. | 1988-01-06 | Traditional | PDF ↗ |
| K873760 | SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER | Coherent Medical Group | 1987-11-27 | Traditional | PDF ↗ |
| K873246 | MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2 | Coherent Medical Group | 1987-11-10 | Traditional | PDF ↗ |
| K873571 | LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE | Laserguide | 1987-11-06 | Traditional | PDF ↗ |
| K873664 | LIGHT-SPOT FIBEROPTIC LASER HANDPIECE | Laserguide | 1987-11-06 | Traditional | PDF ↗ |
| K873963 | COHERENT XA-30 CO2 SURGICAL LASER | Coherent Medical Group | 1987-10-19 | Traditional | PDF ↗ |
| K873773 | ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER | Hgm, Inc. | 1987-10-13 | Traditional | PDF ↗ |
| K872179 | CODMAN NEUROLASE LASER SYSTEM | Codman & Shurtleff, Inc. | 1987-10-07 | Traditional | PDF ↗ |
| K872578 | MDS-90 ARGON DYE LASER FOR DERMATOLOGY | Meditec of America | 1987-10-01 | Traditional | PDF ↗ |
| K872711 | MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY | Directed Energy, Inc. | 1987-09-28 | Traditional | PDF ↗ |
| K872589 | ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR | Class, Inc. | 1987-09-11 | Traditional | PDF ↗ |
| K871619 | LPM-1 (LASER POWER METER) | Bio-Tek Instruments, Inc. | 1987-07-28 | Traditional | PDF ↗ |
| K871206 | LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER | Phase-R Corp. | 1987-07-22 | Traditional | PDF ↗ |
| K871334 | LASE SYSTEM II | Lase, Inc. | 1987-06-01 | Traditional | PDF ↗ |
| K870970 | MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT | Directed Energy, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K870837 | MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE | Directed Energy, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K870971 | MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT | Directed Energy, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K870838 | MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE | Directed Energy, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K870161 | MODEL 5000 MICROMANIPULATOR MICRO CO2 LASER SYSTEM | Coherent Medical Group | 1987-04-14 | Traditional | PDF ↗ |
| K864887 | ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU | Bio Quantum Technologies, Inc. | 1987-04-10 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.