Data / Medical devices / United States / Lightscalpel Inc
Lightscalpel Inc: FDA-registered device maker in Bothell, WA, United States, 7 510(k) clearances
Lightscalpel Inc is registered with the FDA (registration 3008720474) in Bothell, WA, United States. It lists 1 device type. The FDA files 7 510(k) clearances under its listings, the newest dated February 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008720474
- Address
- 11818 North Creek Parkway N, Suite 100, Bothell, WA, United States, 98011
- Owner or operator
- LIGHTSCALPEL, INC. (10033504)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- August 25, 2010
- Registered through
- 2026
- Brand names listed
- LS-1005 CO2 Laser System, LS-2010 DX, LS-2010 FX, LS-2010 SX, LightScalpel, LightScalpel LS-1005 CO2 Laser System, LightScalpel LS-4020 CO2 Laser System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 15, 2023 | K213669 | LIGHTSCALPEL LS-4020 | GEX | Substantially Equivalent | Lightscalpel, Inc. | accessdata.fda.gov |
| September 14, 2018 | K173827 | LightScalpel | GEX | Substantially Equivalent | Lightscalpel, LLC | accessdata.fda.gov |
| October 22, 2014 | K141658 | LIGHT SCALPEL | GEX | Substantially Equivalent | Lightscalpel, LLC | accessdata.fda.gov |
| January 2, 2014 | K132661 | LIGHTSCALPEL | GEX | Substantially Equivalent | Lightscalpel, LLC | accessdata.fda.gov |
| November 29, 2012 | K123037 | LIGHTSCALPEL | GEX | Substantially Equivalent | Lightscalpel, LLC | accessdata.fda.gov |
| July 10, 2012 | K121471 | LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS | GEX | Substantially Equivalent | Lightscalpel, LLC | accessdata.fda.gov |
| June 25, 2008 | K081612 | AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS | GEX | Substantially Equivalent | Aesculight, LLC | accessdata.fda.gov |
Compare with other makers
Updated February 15, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.