Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heraeus Lasersonics, Inc. · Predicate Candidate Screening
38 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
185 days90th percentile
38clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933245 | ULTRALINE II STERILE DISPOSABLE FIBER | Heraeus Lasersonics, Inc. | 1994-04-21 | 293 | 0 |
| K923896 | HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS | Heraeus Lasersonics, Inc. | 1992-11-25 | 113 | 0 |
| K921807 | ULTRALINE STERILE DISPOSABLE FIBER | Heraeus Lasersonics, Inc. | 1992-06-18 | 64 | 0 |
| K915578 | ND;YAG SURGICAL LASER SYSTEMS | Heraeus Lasersonics, Inc. | 1992-06-15 | 185 | 0 |
| K915583 | CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR. | Heraeus Lasersonics, Inc. | 1992-03-27 | 105 | 0 |
| K912618 | LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY | Heraeus Lasersonics, Inc. | 1992-02-27 | 259 | 0 |
| K913887 | C02 LASER WAVEGUIDE | Heraeus Lasersonics, Inc. | 1991-12-09 | 102 | 0 |
| K910530 | CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY | Heraeus Lasersonics, Inc. | 1991-10-31 | 265 | 0 |
| K913918 | HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER | Heraeus Lasersonics, Inc. | 1991-09-25 | 22 | 0 |
| K913564 | HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE | Heraeus Lasersonics, Inc. | 1991-09-16 | 38 | 0 |
| K913513 | LATERALASE STERILE DISPOSABLE FIBER | Heraeus Lasersonics, Inc. | 1991-09-11 | 35 | 0 |
| K911987 | LUXUS 132 ND: YAG SURGICAL LASER SYSTEM | Heraeus Lasersonics, Inc. | 1991-08-13 | 99 | 0 |
| K911408 | CROSSFIRE LASER ASSISTED ASPIRATION CANNULA | Heraeus Lasersonics, Inc. | 1991-06-03 | 63 | 0 |
| K910805 | ND:YAG LASER SYSTEMS (VARIOUS MODELS) | Heraeus Lasersonics, Inc. | 1991-05-24 | 87 | 0 |
| K910496 | CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. | Heraeus Lasersonics, Inc. | 1991-05-06 | 90 | 0 |
| K910894 | HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS | Heraeus Lasersonics, Inc. | 1991-04-22 | 49 | 0 |
| K905637 | ILLUMINA MODEL 780 CO2 LASER SYSTEM | Heraeus Lasersonics, Inc. | 1991-01-18 | 32 | 0 |
| K904610 | HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS | Heraeus Lasersonics, Inc. | 1990-12-19 | 69 | 0 |
| K904423 | CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM | Heraeus Lasersonics, Inc. | 1990-12-13 | 77 | 0 |
| K904444 | MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700 | Heraeus Lasersonics, Inc. | 1990-12-13 | 76 | 0 |
| K903444 | MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 ND:YAG | Heraeus Lasersonics, Inc. | 1990-10-11 | 76 | 0 |
| K902148 | MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700 | Heraeus Lasersonics, Inc. | 1990-07-10 | 56 | 0 |
| K902061 | MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&1700 | Heraeus Lasersonics, Inc. | 1990-07-10 | 64 | 0 |
| K900630 | MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG | Heraeus Lasersonics, Inc. | 1990-05-04 | 85 | 0 |
| K900751 | HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM | Heraeus Lasersonics, Inc. | 1990-05-03 | 69 | 0 |
| K896517 | ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER | Heraeus Lasersonics, Inc. | 1990-02-09 | 86 | 0 |
| K895918 | STERILE DISPOSABLE INFRATIP | Heraeus Lasersonics, Inc. | 1989-12-14 | 65 | 0 |
| K895430 | HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100 | Heraeus Lasersonics, Inc. | 1989-11-28 | 84 | 0 |
| K895263 | ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS | Heraeus Lasersonics, Inc. | 1989-10-20 | 58 | 0 |
| K894164 | MODELS 4000,4900,6000,8000,8900 ND YAG 1700ND | Heraeus Lasersonics, Inc. | 1989-08-29 | 75 | 0 |
| K893832 | CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER | Heraeus Lasersonics, Inc. | 1989-08-09 | 77 | 0 |
| K892211 | HERAEUS LASERSONIC INC. STERILE DISPOSABLE FIBERS | Heraeus Lasersonics, Inc. | 1989-05-19 | 46 | 0 |
| K883379 | MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2 | Heraeus Lasersonics, Inc. | 1989-01-24 | 167 | 0 |
| K885181 | (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 | Heraeus Lasersonics, Inc. | 1989-01-10 | 27 | 0 |
| K883488 | CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. | Heraeus Lasersonics, Inc. | 1988-12-19 | 125 | 0 |
| K883089 | 4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02 | Heraeus Lasersonics, Inc. | 1988-09-28 | 69 | 0 |
| K882365 | HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900 | Heraeus Lasersonics, Inc. | 1988-09-02 | 86 | 0 |
| K881619 | 4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER | Heraeus Lasersonics, Inc. | 1988-07-08 | 86 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda