Lightscalpel, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Lightscalpel, LLC” (first 2012, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 126 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 58 |
| 2013 | 0 | — |
| 2014 | 2 | 126 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 270 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 450 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lightscalpel, LLC took a median 360 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 6 | 6 |
Review panels
Most recent Lightscalpel, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213669 | LIGHTSCALPEL LS-4020 | GEX | 2023-02-15 | 450 |
| K173827 | LightScalpel | GEX | 2018-09-14 | 270 |
| K141658 | LIGHT SCALPEL | GEX | 2014-10-22 | 124 |
| K132661 | LIGHTSCALPEL | GEX | 2014-01-02 | 129 |
| K123037 | LIGHTSCALPEL | GEX | 2012-11-29 | 62 |
| K121471 | LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS | GEX | 2012-07-10 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Lightscalpel, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lightscalpel, LLC?
FDA lists 6 510(k) clearances under the applicant name “Lightscalpel, LLC” (first 2012, latest 2023), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lightscalpel, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lightscalpel, LLC is 126 days.
Which FDA product codes appear under Lightscalpel, LLC?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 6).
Next steps
- See all 6 Lightscalpel, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEX, Lightscalpel, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.