New Star Lasers, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “New Star Lasers, Inc.” (first 1995, latest 2014), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 144 |
| 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 | 27 | 27 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 | 1 |
Review panels
Most recent New Star Lasers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142286 | NS3000 Holmium Laser System | GEX | 2014-10-31 | 74 |
| K132607 | NS 2500 HOLMIUM LASER SYSTEM | GEX | 2014-03-21 | 213 |
| K103338 | COOLTOUCH | PDZ | 2011-11-01 | 351 |
| K101783 | COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE | GEX | 2010-09-13 | 80 |
| K092964 | COOLTOUCH VARIA ND:YAG LASER SYSTEM | GEX | 2009-12-11 | 77 |
| K090410 | COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY | GEX | 2009-03-27 | 37 |
| K081628 | MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO | GEX | 2008-06-20 | 10 |
| K080163 | COOLTOUCH MODELS LC215 AND COOLLIPO | GEX | 2008-04-10 | 78 |
| K072751 | COOLTOUCH MODELS NS 160 AND LC215 COOLIPO | GEX | 2008-01-02 | 97 |
| K072424 | COOLTOUCH, MODEL LC215,COOLLIPO | GEX | 2007-10-03 | 35 |
19 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2016-09-19.
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 New Star Lasers, Inc.?
FDA lists 29 510(k) clearances under the applicant name “New Star Lasers, Inc.” (first 1995, latest 2014), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by New Star Lasers, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name New Star Lasers, Inc. is 78 days.
Which FDA product codes appear under New Star Lasers, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 27); ILY (Lamp, Infrared, Therapeutic Heating, 1); PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis, 1).
Next steps
- See all 29 New Star Lasers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, New Star Lasers, 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.