Light Age, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Light Age, Inc.” (first 1998, latest 2012), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 153 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 | 1 | 165 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 6 | 6 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 | 1 |
Review panels
Most recent Light Age, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113115 | EPICARE YAG | GEX | 2012-04-03 | 165 |
| K110370 | Q-CLEAR | PDZ | 2011-09-15 | 219 |
| K091625 | EPICARE-DUO LASER SYSTEM | GEX | 2009-11-03 | 153 |
| K032991 | LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX | GEX | 2004-09-14 | 355 |
| K033259 | LIGHT AGE Q-CLEAR LASER, MODEL 701-1101 | GEX | 2004-02-25 | 139 |
| K983977 | LIGHT AGE EPICARE ALEXANDRITE LASER | GEX | 1999-01-07 | 59 |
| K980131 | ALEX TA2 ERASER | GEX | 1998-02-17 | 33 |
Recalls
openFDA lists no recalls under a recalling firm named Light Age, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Light Diagnostics (19 510(k)s)
- Light Tree Ventures Europe B.V. (13 510(k)s)
- Light Sources, Inc. (9 510(k)s)
- Light Bioscience, LLC (2 510(k)s)
- Light Force Therapy, Inc. (2 510(k)s)
- Light Instruments (2 510(k)s)
- Light Guide Optics International , Ltd. (1 510(k)s)
- Light Instrument, Ltd. (1 510(k)s)
- Light Relief, LLC (1 510(k)s)
- Light Technology Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Light Age, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Light Age, Inc.” (first 1998, latest 2012), across 2 product codes 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 Light Age, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Light Age, Inc. is 153 days.
Which FDA product codes appear under Light Age, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 6); PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis, 1).
Next steps
- See all 7 Light Age, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Light Age, Inc.'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.