Endo Lase, Inc.: FDA clearances and approvals
Endo Lase, Inc. has 24 FDA 510(k) clearances (first 1984, latest 1986), across 9 product codes in 6 review panels. Median 510(k) review time: 66 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 7 | 7 |
| LNK | Laser For Gastro-Urology Use | 6 | 6 |
| HHR | Laser, Surgical, Gynecologic | 3 | 3 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 2 | 2 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 | 1 |
| LKW | Laser, Neurosurgical | 1 | 1 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 1 | 1 |
Plus 1 more product codes.
Review panels
- Gastroenterology and Urology (8)
- General and Plastic Surgery (7)
- Obstetrics and Gynecology (3)
- Ear, Nose and Throat (2)
- Anesthesiology (1)
- Neurology (1)
Most recent Endo Lase, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853900 | ENDO-LASE CD40 FOR NEUROSURGERY | GEX | 1986-06-18 | 271 |
| K853878 | ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY | GEX | 1986-05-02 | 227 |
| K855093 | MEDILAS 2 ND:YAG LASER SURGERY SYSTEM | HHR | 1986-02-21 | 63 |
| K853903 | ENDO-LASE CD40 CO2 FOR GYNECOLOGY | HHR | 1986-02-21 | 154 |
| K853876 | ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY | HHR | 1986-02-21 | 157 |
| K853901 | ENDO-LASE CD 40 FOR DERMATOLOGY | GEX | 1986-02-19 | 152 |
| K853877 | ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY | GEX | 1986-02-19 | 155 |
| K853580 | MEDILAS 2 | LKW | 1986-02-13 | 171 |
| K860152 | MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY | LNK | 1986-02-05 | 21 |
| K853902 | ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY | EWG | 1986-01-09 | 111 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Endo Lase, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Endo Lase, Inc. have?
Endo Lase, Inc. has 24 FDA 510(k) clearances (first 1984, latest 1986), across 9 product codes in 6 review panels.
How long does FDA take to clear Endo Lase, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Endo Lase, Inc.'s cleared 510(k)s is 66 days.
What devices does Endo Lase, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 7); LNK (Laser For Gastro-Urology Use, 6); HHR (Laser, Surgical, Gynecologic, 3).
Has Endo Lase, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Endo Lase, Inc. Related entities may recall under other names.
Next steps
- See all 24 Endo Lase, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Endo Lase, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.