Endo Lase, Inc.
Walker, MI, US
Endo Lase, Inc. appears in FDA device records in Walker, MI. FDA records list 24 510(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
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Endo Lase, Inc. between 1984 and 1986. The busiest year on record is 1986, with 11. The most recent is 1986, with 11.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 6 |
| 1985 | 7 |
| 1986 | 11 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K853900 | ENDO-LASE CD40 FOR NEUROSURGERY | GEX | Substantially Equivalent | |
| K853878 | ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY | GEX | Substantially Equivalent | |
| K855093 | MEDILAS 2 ND:YAG LASER SURGERY SYSTEM | HHR | Substantially Equivalent | |
| K853903 | ENDO-LASE CD40 CO2 FOR GYNECOLOGY | HHR | Substantially Equivalent | |
| K853876 | ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY | HHR | Substantially Equivalent | |
| K853901 | ENDO-LASE CD 40 FOR DERMATOLOGY | GEX | Substantially Equivalent | |
| K853877 | ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY | GEX | Substantially Equivalent | |
| K853580 | MEDILAS 2 | LKW | Substantially Equivalent | |
| K860152 | MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY | LNK | Substantially Equivalent | |
| K853902 | ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY | EWG | Substantially Equivalent | |
| K853875 | ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY | EWG | Substantially Equivalent | |
| K853904 | ENDO-LASE CD40 FOR UROLOGY | GEX | Substantially Equivalent | |
| K853874 | ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA- | GEX | Substantially Equivalent | |
| K852507 | ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION | LLO | Substantially Equivalent | |
| K851527 | UTILIZATION OF ND:YAG LASER FOR TREATMENT RECTAL P | GEX | Substantially Equivalent | |
| K844460 | ND. YAG LASER RECTAL PATHOLOGY | LNK | Substantially Equivalent | |
| K844459 | ND:YAG LASER UROLOGICAL SURGERY | LNK | Substantially Equivalent | |
| K844458 | ND:YAG LASER PULMONARY OBSTRUCTION | Substantially Equivalent | ||
| K842810 | INFRARED COAGULATOR | KNS | Substantially Equivalent | |
| K843374 | ND-YAG LASER FOR PALLIATION OF GI MALIGN | LNK | Substantially Equivalent | |
| K843293 | ND-YAG LASER FOR UROLOGICAL SURGERY | LNK | Substantially Equivalent | |
| K843228 | ND. YAG LASER FOR ENDOBRONCHIAL OBSTRUC | Substantially Equivalent | ||
| K834487 | FLEXIBLE LIQUID LIGHT GUIDE | FFS | Substantially Equivalent | |
| K833557 | MEDILAS LASER | LNK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FFSImage, Illumination, Fiberoptic, For Endoscope
- LNKLaser For Gastro-Urology Use
- EWGLaser, Ent Microsurgical Carbon-Dioxide
- LLOLaser, Neodymium:Yag, Pulmonary Surgery
- LKWLaser, Neurosurgical
- HHRLaser, Surgical, Gynecologic
- GEXPowered Laser Surgical Instrument
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
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