Luxtec Corp.
Sturbridge, MA, US
Luxtec Corp. appears in FDA device records in Sturbridge, MA. FDA records list 15 510(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
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Luxtec Corp. between 1986 and 1997. The busiest year on record is 1987, with 5. The most recent is 1997, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 4 |
| 1987 | 5 |
| 1989 | 2 |
| 1995 | 1 |
| 1997 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973193 | LUXSCOPE | HQF | Substantially Equivalent | |
| K970642 | TENOSCOPE | HRX | Substantially Equivalent | |
| K970562 | TENOSNARE | HRX | Substantially Equivalent | |
| K950960 | REDDY ILLUMINATOR | FFS | Substantially Equivalent | |
| K895248 | IMS5000 ILLUMINATED LOUPES | FSP | Substantially Equivalent | |
| K890716 | LUXTEC ACO SERIES 4000 LIGHT SOURCE | FCW | Substantially Equivalent | |
| K864387 | LUXTEC FIBEROPTIC CABLES | EQH | Substantially Equivalent | |
| K864383 | LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS | EQH | Substantially Equivalent | |
| K864382 | FRAZIER SUCTION TUBE | EQH | Substantially Equivalent | |
| K864385 | LUXTEC LIGHT SOURCES | FCW | Substantially Equivalent | |
| K864865 | SPECULUM, VAGINAL, METAL FIBEROPTIC | HDG | Substantially Equivalent | |
| K864381 | LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM | FWC | Substantially Equivalent | |
| K864384 | LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS | GAD | Substantially Equivalent | |
| K864380 | LUTEX HEADLIGHT SYSTEMS | FST | Substantially Equivalent | |
| K864386 | LUXTEC LOUPES FOR SURGICAL VISION | FSP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HRXArthroscope
- FWCCamera, Television, Surgical, With Audio
- FFSImage, Illumination, Fiberoptic, For Endoscope
- HQFLaser, Ophthalmic
- FCWLight Source, Fiberoptic, Routine
- FSTLight, Surgical, Fiberoptic
- FSPLoupe, Diagnostic/Surgical
- GADRetractor
- EQHSource, Carrier, Fiberoptic Light
- HDGSpeculum, Vaginal, Metal, Fiberoptic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Luxtec Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Luxtec Corp.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain