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 29 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K870517 | 0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE | Coherent Medical Group | 1987-04-10 | Traditional | PDF ↗ |
| K864563 | MODEL LS 840, CO2 LASER | Cooper Lasersonics, Inc. | 1987-04-09 | Traditional | PDF ↗ |
| K864562 | MODEL LS 860, CO2 LASER | Cooper Lasersonics, Inc. | 1987-04-09 | Traditional | PDF ↗ |
| K862514 | OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO | Laserscope | 1987-02-04 | Traditional | PDF ↗ |
| K863086 | SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG | Cooper Lasersonics, Inc. | 1986-12-04 | Traditional | PDF ↗ |
| K861179 | CANDELA MODEL SPT-1, PULSED DYE LASER | Candela Corp. | 1986-11-20 | Traditional | PDF ↗ |
| K862815 | LASER SURGICAL ROD | Lifestream Int'L, Inc. | 1986-11-17 | Traditional | PDF ↗ |
| K861044 | MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND | Sharplan Industries, Inc. | 1986-10-28 | Traditional | PDF ↗ |
| K863183 | ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY | Cooper Lasersonics, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K862863 | MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE | Directed Energy, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K862864 | MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY | Directed Energy, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K862408 | MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG | Directed Energy, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K861688 | XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 | Xanar, Inc. | 1986-10-03 | Traditional | PDF ↗ |
| K862422 | MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY | Directed Energy, Inc. | 1986-10-02 | Traditional | PDF ↗ |
| K860831 | MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED) | Cooper Lasersonics, Inc. | 1986-10-02 | Traditional | PDF ↗ |
| K862862 | MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY | Directed Energy, Inc. | 1986-09-19 | Traditional | PDF ↗ |
| K863433 | MODEL 8900 ND:YAG LASER | Cooper Lasersonics, Inc. | 1986-09-17 | Traditional | PDF ↗ |
| K862423 | MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY | Directed Energy, Inc. | 1986-09-15 | Traditional | PDF ↗ |
| K862472 | QUARTZ RODS TITANIUM RODS | Quali-Med, Inc. | 1986-09-12 | Traditional | PDF ↗ |
| K853117 | COOPER LASER SONICS ND: YAG LASER, MODEL 8008 | Cooper Lasersonics, Inc. | 1986-08-12 | Traditional | PDF ↗ |
| K860083 | DERMASCAN LASER SURGICAL HANDPIECE | Medical Laser Research & Development Corp. | 1986-08-07 | Traditional | PDF ↗ |
| K860974 | MODEL 545-45 LASER FOR DERMA., POD., SURGICAL | Britt Corp., Inc. | 1986-07-07 | Traditional | PDF ↗ |
| K854468 | PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC | Minnesota Laser Corp. | 1986-06-20 | Traditional | PDF ↗ |
| K854473 | PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC | Minnesota Laser Corp. | 1986-06-20 | Traditional | PDF ↗ |
| K853900 | ENDO-LASE CD40 FOR NEUROSURGERY | Endo Lase, Inc. | 1986-06-18 | Traditional | PDF ↗ |
| K855210 | SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT | Directed Energy, Inc. | 1986-05-02 | Traditional | PDF ↗ |
| K854998 | SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC | Directed Energy, Inc. | 1986-05-02 | Traditional | PDF ↗ |
| K853878 | ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY | Endo Lase, Inc. | 1986-05-02 | Traditional | PDF ↗ |
| K860087 | SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM | Sharplan Lasers, Inc. | 1986-04-24 | Traditional | PDF ↗ |
| K860273 | MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY | Britt Corp., Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K852436 | AMBULASE | Xanar, Inc. | 1986-04-18 | Traditional | PDF ↗ |
| K860278 | MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC | Britt Corp., Inc. | 1986-04-15 | Traditional | PDF ↗ |
| K854833 | MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI | Meditec, Inc. | 1986-04-04 | Traditional | PDF ↗ |
| K854386 | MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM | Directed Energy, Inc. | 1986-03-28 | Traditional | PDF ↗ |
| K855246 | AURORA M MEDICAL DYE LASER | Cooper Lasersonics, Inc. | 1986-03-21 | Traditional | PDF ↗ |
| K853901 | ENDO-LASE CD 40 FOR DERMATOLOGY | Endo Lase, Inc. | 1986-02-19 | Traditional | PDF ↗ |
| K853877 | ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY | Endo Lase, Inc. | 1986-02-19 | Traditional | PDF ↗ |
| K854472 | PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG | Minnesota Laser Corp. | 1986-02-11 | Traditional | PDF ↗ |
| K854469 | PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG | Minnesota Laser Corp. | 1986-02-11 | Traditional | PDF ↗ |
| K854398 | MODEL CO2 LASER SYSTEM 8B | Directed Energy, Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K854387 | MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM | Directed Energy, Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K854134 | FIBEROPTIC COLLIMATING HANDPIECE | Dawn Laser Technology, Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K853626 | CODMAN LASER BACKSTOP | Codman & Shurtleff, Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K853627 | CODMAN LASER RODS | Codman & Shurtleff, Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K854399 | MODEL 20-B CO2 LASER SYSTEM | Directed Energy, Inc. | 1986-02-07 | Traditional | PDF ↗ |
| K853620 | MODEL XA-50 - CO2 SURGICAL LASER | Xanar, Inc. | 1986-01-24 | Traditional | PDF ↗ |
| K852470 | SURGILASE 40S | Surgilase, Inc. | 1985-11-13 | Traditional | PDF ↗ |
| K853874 | ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA- | Endo Lase, Inc. | 1985-10-25 | Traditional | PDF ↗ |
| K853904 | ENDO-LASE CD40 FOR UROLOGY | Endo Lase, Inc. | 1985-10-25 | Traditional | PDF ↗ |
| K844178 | MODEL TT25RF | Inframed, Inc. | 1985-10-18 | Traditional | PDF ↗ |
| K851405 | TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 | Trimedyne, Inc. | 1985-10-07 | Traditional | PDF ↗ |
| K852860 | MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE | Coherent Medical Group | 1985-10-07 | Traditional | PDF ↗ |
| K852696 | FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY | Minnesota Laser Corp. | 1985-09-19 | Traditional | PDF ↗ |
| K853319 | MINI-HALO(HAND-HELD) CO2 LASER SYSTEM | Directed Energy, Inc. | 1985-09-19 | Traditional | PDF ↗ |
| K852190 | MODEL 451 CO2 SURGICAL LASER | Coherent Medical Group | 1985-08-23 | Traditional | PDF ↗ |
| K852122 | MEDILASER MIC MODEL MEL-445C, 15W | Mochida Pharmaceutical Co., Ltd. | 1985-08-20 | Traditional | PDF ↗ |
| K852121 | MEDILASER MIC MODEL MEL 440-C;30W | Mochida Pharmaceutical Co., Ltd. | 1985-08-20 | Traditional | PDF ↗ |
| K850805 | CO 2 SURGICAL LASER SYSTEM MODEL NA-40 | Xanar, Inc. | 1985-08-15 | Traditional | PDF ↗ |
| K850804 | CO 2 SURGICAL LASER SYSTEM NA-30 | Xanar, Inc. | 1985-08-15 | Traditional | PDF ↗ |
| K850818 | CO 2 SURGICAL LASER SYSTEM NA-120 | Xanar, Inc. | 1985-08-15 | Traditional | PDF ↗ |
| K851000 | COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY | Cooper Lasersonics, Inc. | 1985-08-14 | Traditional | PDF ↗ |
| K850628 | SHARPLAN 1040 CO/2 SURGICAL LASER | Laser Industries , Ltd. | 1985-08-07 | Traditional | PDF ↗ |
| K850633 | SHARPLAN MODEL 1060 CO/2 SURGICAL LASER | Laser Industries , Ltd. | 1985-08-07 | Traditional | PDF ↗ |
| K852252 | 870 SURGICAL SYS CONTROL PULSE MODIFICATION | Cooper Lasersonics, Inc. | 1985-06-27 | Traditional | PDF ↗ |
| K850018 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYS ND:YAG | Laserscope | 1985-06-18 | Traditional | PDF ↗ |
| K851527 | UTILIZATION OF ND:YAG LASER FOR TREATMENT RECTAL P | Endo Lase, Inc. | 1985-05-17 | Traditional | PDF ↗ |
| K843915 | MINI-HALO CO2 LASER SYSTEM | CooperVision, Inc. | 1985-05-10 | Traditional | PDF ↗ |
| K844644 | SURGICAL LASER MICRO-TIPS | Surgical Laser Technologies, Inc. | 1985-05-10 | Traditional | PDF ↗ |
| K844643 | S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS | Surgical Laser Technologies, Inc. | 1985-05-10 | Traditional | PDF ↗ |
| K850779 | MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT | Cooper Lasersonics, Inc. | 1985-04-02 | Traditional | PDF ↗ |
| K850985 | FLEXUS 2 CO2 SURGICAL LASER SYSTEM | Intl. Solarium Manufacturer, Inc. | 1985-03-25 | Traditional | PDF ↗ |
| K841781 | MODEL 305AA PORTABLE LASER | Laser Spectrum, Inc. | 1984-11-07 | Traditional | PDF ↗ |
| K842703 | ND-YAG LASER 8000 NEUROSURGERY APPLICA | Cooper Lasersonics, Inc. | 1984-10-31 | Traditional | PDF ↗ |
| K840739 | MEDILASER-S MEL-444-S | Mochida Pharmaceutical Co., Ltd. | 1984-09-20 | Traditional | PDF ↗ |
| K834166 | BARD CO2 SURGICAL LASER SYS SLS-50/100 | C.R. Bard, Inc. | 1984-09-18 | Traditional | PDF ↗ |
| K840406 | MICROSURGICAL CO2 LASER SYS - 4100 | Bio Quantum Technologies, Inc. | 1984-08-20 | Traditional | PDF ↗ |
| K841234 | HALO CO LASER SYSTEM | Directed Energy, Inc. | 1984-07-09 | Traditional | PDF ↗ |
| K832550 | SHARPLAN #734 LASER SURGICAL UNIT | Laser Industries , Ltd. | 1984-04-25 | Traditional | PDF ↗ |
| K832983 | DERMOLAS | Meditec, Inc. | 1984-04-23 | Traditional | PDF ↗ |
| K820327 | MODEL 450XL CO2 SURGICAL LASER | Lumenis, Inc. | 1982-03-08 | Traditional | PDF ↗ |
| K820101 | SHARPLAN 720 CO2 SURGICAL LASER | Laser Industries , Ltd. | 1982-02-24 | Traditional | PDF ↗ |
| K801624 | SHARPLAN 723 CO2 LASER SURGICAL SYSTEM | Laser Industries , Ltd. | 1980-08-20 | Traditional | PDF ↗ |
| K792418 | SHARPLAN 743, CO2 LASER SURGICAL SYSTEM | Laser Industries , Ltd. | 1980-02-05 | Traditional | PDF ↗ |
| K791895 | ACCESSORIES FOR SYS. 400 CO2 SURG. LASER | Coherent Medical Division | 1979-12-20 | Traditional | PDF ↗ |
| K782030 | LASER SYSTEM, SHARPLAN 791/HE, CO2 | Laser Industries , Ltd. | 1979-01-22 | Traditional | PDF ↗ |
| K781453 | MODEL 770 ARGON LASER | Spectra-Physics, Inc. | 1978-10-24 | Traditional | PDF ↗ |
| K780585 | SURGICAL LASER | Laser Industries , Ltd. | 1978-07-19 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.