Heraeus Lasersonics, Inc.
Santa Clara, CA, US
Heraeus Lasersonics, Inc. appears in FDA device records in Santa Clara, CA. FDA records list 38 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 38
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 38 510(k) clearances for Heraeus Lasersonics, Inc. between 1988 and 1994. The busiest year on record is 1991, with 11. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 4 |
| 1989 | 8 |
| 1990 | 9 |
| 1991 | 11 |
| 1992 | 5 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K933245 | ULTRALINE II STERILE DISPOSABLE FIBER | GEX | Substantially Equivalent | |
| K923896 | HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS | GEX | Substantially Equivalent | |
| K921807 | ULTRALINE STERILE DISPOSABLE FIBER | GEX | Substantially Equivalent | |
| K915578 | ND;YAG SURGICAL LASER SYSTEMS | GEX | Substantially Equivalent | |
| K915583 | CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR. | GEX | Substantially Equivalent | |
| K912618 | LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY | GEX | Substantially Equivalent | |
| K913887 | C02 LASER WAVEGUIDE | GEX | Substantially Equivalent | |
| K910530 | CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY | GEX | Substantially Equivalent | |
| K913918 | HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER | GEX | Substantially Equivalent | |
| K913564 | HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE | GEX | Substantially Equivalent | |
| K913513 | LATERALASE STERILE DISPOSABLE FIBER | GEX | Substantially Equivalent | |
| K911987 | LUXUS 132 ND: YAG SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K911408 | CROSSFIRE LASER ASSISTED ASPIRATION CANNULA | GEX | Substantially Equivalent | |
| K910805 | ND:YAG LASER SYSTEMS (VARIOUS MODELS) | HQF | Substantially Equivalent | |
| K910496 | CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. | GEX | Substantially Equivalent | |
| K910894 | HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS | GEX | Substantially Equivalent | |
| K905637 | ILLUMINA MODEL 780 CO2 LASER SYSTEM | GEX | Substantially Equivalent | |
| K904610 | HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS | GEX | Substantially Equivalent | |
| K904444 | MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700 | GEX | Substantially Equivalent | |
| K904423 | CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM | GEX | Substantially Equivalent | |
| K903444 | MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 ND:YAG | GEX | Substantially Equivalent | |
| K902148 | MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700 | GEX | Substantially Equivalent | |
| K902061 | MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&1700 | GEX | Substantially Equivalent | |
| K900630 | MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG | GEX | Substantially Equivalent | |
| K900751 | HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM | GEX | Substantially Equivalent | |
| K896517 | ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER | GEX | Substantially Equivalent | |
| K895918 | STERILE DISPOSABLE INFRATIP | GEX | Substantially Equivalent | |
| K895430 | HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100 | GEX | Substantially Equivalent | |
| K895263 | ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS | GEX | Substantially Equivalent | |
| K894164 | MODELS 4000,4900,6000,8000,8900 ND YAG 1700ND | GEX | Substantially Equivalent | |
| K893832 | CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER | GEX | Substantially Equivalent | |
| K892211 | HERAEUS LASERSONIC INC. STERILE DISPOSABLE FIBERS | GEX | Substantially Equivalent | |
| K883379 | MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2 | GEX | Substantially Equivalent | |
| K885181 | (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 | GEX | Substantially Equivalent | |
| K883488 | CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. | GEX | Substantially Equivalent | |
| K883089 | 4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02 | GEX | Substantially Equivalent | |
| K882365 | HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900 | GEX | Substantially Equivalent | |
| K881619 | 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain