Lightscalpel, LLC

FDA Regulatory Profile

Lightscalpel, LLC has 0 FDA recalls, 5 inspections, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 2, 2022 · NAI
Latest 510(k)
Feb 15, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances6Oct 4, 2026Not statedCurrent
Inspections5Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 2, 2022Bothell, WADevicesNo Action Indicated (NAI)3008720474
Mar 13, 2019Bothell, WADevicesNo Action Indicated (NAI)3008720474
Jun 29, 2016Bothell, WADevicesVoluntary Action Indicated (VAI)3008720474
Feb 27, 2014Bothell, WADevicesVoluntary Action Indicated (VAI)3008720474
Jan 24, 2012Bothell, WADevicesNo Action Indicated (NAI)3008720474

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K213669LIGHTSCALPEL LS-4020Feb 15, 2023
K173827LightScalpelSep 14, 2018
K141658LIGHT SCALPELOct 22, 2014
K132661LIGHTSCALPELJan 2, 2014
K123037LIGHTSCALPELNov 29, 2012
K121471LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERSJul 10, 2012