Shaser, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Shaser, Inc.” (first 2011, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 123 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 | 135 |
| 2013 | 3 | 134 |
| 2014 | 3 | 65 |
| 2015 | 2 | 120 |
| 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 |
|---|---|---|---|
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 9 | 9 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
Review panels
Most recent Shaser, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Acne | ONF | 2015-05-27 | 111 |
| K142924 | Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family | GEX | 2015-02-13 | 128 |
| K141583 | SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY | ONF | 2014-07-22 | 39 |
| K140631 | LUMENA FH HAIR REMOVAL SYSTEM | ONF | 2014-05-16 | 65 |
| K133201 | SHASER V-MINI 2 HAIR REMOVAL SYSTEM | ONF | 2014-02-12 | 118 |
| K132170 | SHASER V-MINI RX | ONF | 2013-11-26 | 134 |
| K132266 | SHASER HRS2 RX HAIR REMOVAL SYSTEM | ONF | 2013-09-30 | 70 |
| K130015 | SHASER V-MINI HAIR REMOVAL SYSTEM | ONF | 2013-06-13 | 161 |
| K120080 | SHASER HRS2 HAIR REMOVAL SYSTEM | ONF | 2012-05-25 | 135 |
| K103560 | SHASER IPL HAIR REMOVAL SYSTEM | ONF | 2011-05-18 | 166 |
Recalls
openFDA lists no recalls under a recalling firm named Shaser, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Shaser, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Shaser, Inc.” (first 2011, latest 2015), 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 Shaser, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shaser, Inc. is 123 days.
Which FDA product codes appear under Shaser, Inc.?
The most frequent FDA product codes under this applicant name are ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, 9); GEX (Powered Laser Surgical Instrument, 1).
Next steps
- See all 10 Shaser, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ONF, Shaser, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.