FDA Product Code
FDA Product Code HQF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4390
510(k) Clearances — 180 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K960971 | OCULIGHT GL | Iriderm Div. | 1996-08-28 | Traditional | PDF ↗ |
| K960522 | DIOPEXY PROBE | Iriderm Div. | 1996-07-19 | Traditional | PDF ↗ |
| K951079 | NIDEK MODEL GYC-1500 AND GYC-2000 | Nidek, Inc. | 1995-09-14 | Traditional | PDF ↗ |
| K952894 | VISULINK 900 ARGON | Carl Zeiss, Inc. | 1995-08-14 | Traditional | PDF ↗ |
| K942180 | KEELER MULTILASE 3000 | Keeler Instruments, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K935747 | MEGABEAM ENDOCULAR PROBE | Ceram Optec, Inc. | 1994-04-01 | Traditional | PDF ↗ |
| K931784 | HGM ILLUMINATING IMAGING ENDOCULAR PROBE | Hgm, Inc. | 1994-03-01 | Traditional | PDF ↗ |
| K932836 | NIDEK MODEL AC-2300 | Nidek, Inc. | 1993-11-22 | Traditional | PDF ↗ |
| K932296 | JR -- OPHTHALMIC ARGON LASER | Carson Laserworks | 1993-11-12 | Traditional | PDF ↗ |
| K925663 | HGM ASPIRATING ENDOOCULAR(TM) PROBE | Hgm, Inc. | 1993-08-17 | Traditional | PDF ↗ |
| K926470 | LASER AND EMPHASIS SCLEROSTOMY TIP | Summit Technology, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K910532 | URAM OPHTHALMIC LASER ENDOSCOPE | Martin S. Knopf Assoc., Inc. | 1991-05-28 | Traditional | PDF ↗ |
| K910805 | ND:YAG LASER SYSTEMS (VARIOUS MODELS) | Heraeus Lasersonics, Inc. | 1991-05-24 | Traditional | PDF ↗ |
| K904699 | COMPAC(TM) DIODE LASERS | Hgm Medical Laser Systems, Inc. | 1991-04-25 | Traditional | PDF ↗ |
| K905453 | CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND | Douglas James Donaldson Compliance Services | 1991-03-05 | Traditional | PDF ↗ |
| K910612 | CANDELA DIODE TRABECULOPLASTY LASER DTL | Candela Laser Corp. | 1991-03-04 | Traditional | PDF ↗ |
| K905141 | CENTAURI | Pfizer Laser Systems | 1991-02-11 | Traditional | PDF ↗ |
| K903421 | TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER | Top Con | 1990-12-18 | Traditional | PDF ↗ |
| K904366 | CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR | Douglas James Donaldson Compliance Services | 1990-10-19 | Traditional | PDF ↗ |
| K900199 | LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTY | Lasag AG | 1990-03-27 | Traditional | PDF ↗ |
| K895213 | MICROLASE BY LASER TRABECULOPLASTY | Keeler Instruments, Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K895196 | MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR | Nidek, Inc. | 1989-10-16 | Traditional | PDF ↗ |
| K894835 | LASERMED* GOGGLES AND SPECTACLES | Glendale Protective Technologies, Inc. | 1989-09-21 | Traditional | PDF ↗ |
| K894273 | NIDEK MODEL AKC-8000 | Nidek, Inc. | 1989-08-07 | Traditional | PDF ↗ |
| K893630 | CANDELA UPC LASER PHOTOCOAGULATOR | Candela Laser Corp. | 1989-08-02 | Traditional | PDF ↗ |
| K893709 | COHERENT MARIE ARGON PHOTOCOAGULATOR | Coherent Medical Group | 1989-06-15 | Traditional | PDF ↗ |
| K890509 | INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM | Biophysic Medical, Inc. | 1989-03-24 | Traditional | PDF ↗ |
| K890086 | MICROLASE 8 0 0 (OPHTHALMIC LASER) | Keeler Instruments, Inc. | 1989-03-15 | Traditional | PDF ↗ |
| K885164 | LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM | Chiron Vision Corp. | 1989-01-10 | Traditional | PDF ↗ |
| K882908 | SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA. | Surgical Laser Technologies, Inc. | 1988-09-30 | Traditional | PDF ↗ |
| K883213 | NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS) | Nidek, Inc. | 1988-09-15 | Traditional | PDF ↗ |
| K881494 | FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER | Biophysic Medical, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K882372 | RESUBMITTED DIODE LASER COAGULATOR | CooperVision, Inc. | 1988-08-02 | Traditional | PDF ↗ |
| K881134 | SLT CONTACT LASER SYSTEM OCULOPLASTICS | Surgical Laser Technologies, Inc. | 1988-06-06 | Traditional | PDF ↗ |
| K875000 | PRISMA DISPOSABLE ENDO-OCULAR PROBE | Advanced Surgical Products, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K874609 | ZEISS VISULAS ARGON LASER | Carl Zeiss, Inc. | 1988-01-06 | Traditional | PDF ↗ |
| K873460 | OPHTHALAS DYE OPHTHALMIC LASER | Biophysic Medical, Inc. | 1987-10-29 | Traditional | PDF ↗ |
| K872846 | NIDEK ADC-8000 LASER SYSTEM | Nidek, Inc. | 1987-10-15 | Traditional | PDF ↗ |
| K870839 | MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC | Directed Energy, Inc. | 1987-05-22 | Traditional | PDF ↗ |
| K864063 | ORION 3001, LASER PHOTOCOAGULATOR | G. Rodenstock Instrumente GmbH | 1986-11-13 | Traditional | PDF ↗ |
| K863246 | MIRALITE | Mira, Inc. | 1986-10-31 | Traditional | PDF ↗ |
| K863591 | ENDOPHOTOCOAGULATION PROBE | Mira, Inc. | 1986-10-10 | Traditional | PDF ↗ |
| K862568 | LDS - LASER DELIVERY SYSTEM | Coherent Medical Group | 1986-10-07 | Traditional | PDF ↗ |
| K862987 | MODEL 1000 OPHTHALMIC LASER SYSTEM | CooperVision, Inc. | 1986-09-24 | Traditional | PDF ↗ |
| K860358 | FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE) | Hgm, Inc. | 1986-03-21 | Traditional | PDF ↗ |
| K854949 | MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS | CooperVision, Inc. | 1986-02-04 | Traditional | PDF ↗ |
| K854288 | OPHALMIC LASER PHOTOCOAGULATOR | Mira, Inc. | 1985-11-12 | Traditional | PDF ↗ |
| K853890 | OPHTHALMIC LASER PHOTOCOAGULATOR | Mira, Inc. | 1985-11-12 | Traditional | PDF ↗ |
| K852529 | HESSBURG GLIDE UNTRAOCULAR LENS GUIDES | Visitec Co. | 1985-09-24 | Traditional | PDF ↗ |
| K852234 | MDS 83 OPHTHALMIC DYE LASER SYSTEM | Meditec, Inc. | 1985-08-01 | Traditional | PDF ↗ |
| K852464 | HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C. | Hcg, Inc. | 1985-07-25 | Traditional | PDF ↗ |
| K844357 | SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR | Coherent Medical Group | 1985-06-05 | Traditional | PDF ↗ |
| K850572 | HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K | Hgm, Inc. | 1985-04-23 | Traditional | PDF ↗ |
| K844358 | SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP | Coherent Medical Group | 1985-01-03 | Traditional | PDF ↗ |
| K844668 | MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE | Cooper Lasersonics, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K843965 | ARGON LASER PHOTOCOAGULATOR SYS | American Medical Optics | 1984-11-06 | Traditional | PDF ↗ |
| K842250 | AMER. MEDICAL OPTICS ARGON/KRYPTON LASE | American Medical Optics | 1984-08-15 | Traditional | PDF ↗ |
| K842251 | AMERI. MEDICAL OPTICS ARGON LASER PHOTO | American Medical Optics | 1984-08-15 | Traditional | PDF ↗ |
| K842412 | MODEL 4000 MD-YAG LASER FOR MALIGNANT | Cooper Lasersonics, Inc. | 1984-06-26 | Traditional | PDF ↗ |
| K841855 | AMER. MED. OPTICS ARGON LASER PHOTO | American Medical Optics | 1984-06-19 | Traditional | PDF ↗ |
| K841856 | AMER. MED. OPTICS ARGON/KRYPTON LASER | American Medical Optics | 1984-06-07 | Traditional | PDF ↗ |
| K840590 | FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE | Hgm, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K840145 | MONITOR CO2 LASER SURGICAL SYSTEM | Cooper Lasersonics, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K834610 | LASER LENS-VARIOUS MODELS | Meditec of America | 1984-04-05 | Traditional | PDF ↗ |
| K840854 | MEDICAL LASER ENDOCOAGULATOR 5K | Hgm, Inc. | 1984-04-02 | Traditional | PDF ↗ |
| K834305 | ARGON/KRYPTON ION LASER PHOTOCOAGULA | Nidek, Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K833532 | OCULASE 514 OPHTHALMIC ARGON LASER | Lasermed Corp. | 1984-02-04 | Traditional | PDF ↗ |
| K834060 | RELIANCE OPHTHALMIC SLIT LAMP R-083 | F. & F. Koenigkramer | 1984-02-04 | Traditional | PDF ↗ |
| K832089 | MODEL 150K LASER COAGULATOR | Lasertek OY | 1984-01-30 | Traditional | PDF ↗ |
| K832316 | OPHTHALMIC ARGON LASER #700A | Laser Industries , Ltd. | 1984-01-30 | Traditional | PDF ↗ |
| K833533 | LASER PHOTOCOAGULATOR 1520-A & K | Britt Corp., Inc. | 1984-01-30 | Traditional | PDF ↗ |
| K833232 | LASER PROTECTIVE EYESHIELD | Stefanovsky & Assoc. | 1983-12-30 | Traditional | PDF ↗ |
| K833274 | DERMATOLOGY HANDPIECE-OPHTH LASER | Synemed, Inc. | 1983-12-03 | Traditional | PDF ↗ |
| K813492 | BRITT KRYPTON LASERS 150K & 152K | Britt Corp., Inc. | 1982-01-22 | Traditional | PDF ↗ |
| K812219 | MODEL 900S INTRAOCULAR PROBE | Lumenis, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K801336 | MODEL 900K PHOTOCOAGULATOR | Coherent Medical Division | 1980-07-28 | Traditional | PDF ↗ |
| K791659 | MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL | Coburn Optical Ind., Inc. | 1979-10-11 | Traditional | PDF ↗ |
| K781965 | LASER COAGULATOR, MODEL 41AK | Lasertek OY | 1979-02-08 | Traditional | PDF ↗ |
| K782106 | COAGULATOR, MODEL 40 AARGON | Lasertek OY | 1979-02-08 | Traditional | PDF ↗ |
| K782065 | LASER, PHOTOCOAGULATION | Cavitron Corp. | 1978-12-28 | Traditional | PDF ↗ |
Product code HQF · Class II · Ophthalmic. Data: openFDA.