Lightscalpel Inc
Bothell, WA, US
LIGHTSCALPEL INC appears in FDA device records in Bothell, WA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Lightscalpel Inc between 2012 and 2023. The busiest year on record is 2012, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 2 |
| 2014 | 2 |
| 2018 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213669 | LIGHTSCALPEL LS-4020 | GEX | Substantially Equivalent | |
| K173827 | LightScalpel | GEX | Substantially Equivalent | |
| K141658 | LIGHT SCALPEL | GEX | Substantially Equivalent | |
| K132661 | LIGHTSCALPEL | GEX | Substantially Equivalent | |
| K123037 | LIGHTSCALPEL | GEX | Substantially Equivalent | |
| K121471 | LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008720474 | 3008720474 | LIGHTSCALPEL INC | 11818 North Creek Parkway N, Suite 100, Bothell, WA 98011 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
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