Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shaser, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
128 daysmedian FDA review time
166 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Ac | Shaser, Inc. | 2015-05-27 | 111 | 0 |
| K142924 | Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Fa | Shaser, Inc. | 2015-02-13 | 128 | 0 |
| K141583 | SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY | Shaser, Inc. | 2014-07-22 | 39 | 0 |
| K140631 | LUMENA FH HAIR REMOVAL SYSTEM | Shaser, Inc. | 2014-05-16 | 65 | 0 |
| K133201 | SHASER V-MINI 2 HAIR REMOVAL SYSTEM | Shaser, Inc. | 2014-02-12 | 118 | 0 |
| K132170 | SHASER V-MINI RX | Shaser, Inc. | 2013-11-26 | 134 | 0 |
| K132266 | SHASER HRS2 RX HAIR REMOVAL SYSTEM | Shaser, Inc. | 2013-09-30 | 70 | 0 |
| K130015 | SHASER V-MINI HAIR REMOVAL SYSTEM | Shaser, Inc. | 2013-06-13 | 161 | 0 |
| K120080 | SHASER HRS2 HAIR REMOVAL SYSTEM | Shaser, Inc. | 2012-05-25 | 135 | 0 |
| K103560 | SHASER IPL HAIR REMOVAL SYSTEM | Shaser, Inc. | 2011-05-18 | 166 | 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