Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lightscalpel, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
124 daysmedian FDA review time
270 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173827 | LightScalpel | Lightscalpel, LLC | 2018-09-14 | 270 | 0 |
| K141658 | LIGHT SCALPEL | Lightscalpel, LLC | 2014-10-22 | 124 | 0 |
| K132661 | LIGHTSCALPEL | Lightscalpel, LLC | 2014-01-02 | 129 | 0 |
| K123037 | LIGHTSCALPEL | Lightscalpel, LLC | 2012-11-29 | 62 | 0 |
| K121471 | LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASER | Lightscalpel, LLC | 2012-07-10 | 53 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda