Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
New Star Lasers, Inc. — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
237 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142286 | NS3000 Holmium Laser System | New Star Lasers, Inc. | 2014-10-31 | 74 | 1 |
| K132607 | NS 2500 HOLMIUM LASER SYSTEM | New Star Lasers, Inc. | 2014-03-21 | 213 | 0 |
| K103338 | COOLTOUCH | New Star Lasers, Inc. | 2011-11-01 | 351 | 0 |
| K101783 | COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE | New Star Lasers, Inc. | 2010-09-13 | 80 | 0 |
| K092964 | COOLTOUCH VARIA ND:YAG LASER SYSTEM | New Star Lasers, Inc. | 2009-12-11 | 77 | 0 |
| K090410 | COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY | New Star Lasers, Inc. | 2009-03-27 | 37 | 0 |
| K081628 | MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO | New Star Lasers, Inc. | 2008-06-20 | 10 | 0 |
| K080163 | COOLTOUCH MODELS LC215 AND COOLLIPO | New Star Lasers, Inc. | 2008-04-10 | 78 | 0 |
| K072751 | COOLTOUCH MODELS NS 160 AND LC215 COOLIPO | New Star Lasers, Inc. | 2008-01-02 | 97 | 0 |
| K072424 | COOLTOUCH, MODEL LC215,COOLLIPO | New Star Lasers, Inc. | 2007-10-03 | 35 | 0 |
| K061618 | COOLTOUCH, MODEL CTEV | New Star Lasers, Inc. | 2006-09-25 | 108 | 0 |
| K062210 | COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 | New Star Lasers, Inc. | 2006-09-25 | 55 | 0 |
| K051434 | COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV | New Star Lasers, Inc. | 2005-08-09 | 69 | 0 |
| K043046 | COOLTOUCH, MODEL CT3S | New Star Lasers, Inc. | 2005-02-01 | 89 | 0 |
| K041323 | PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA | New Star Lasers, Inc. | 2004-11-17 | 183 | 0 |
| K040131 | COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYST | New Star Lasers, Inc. | 2004-04-20 | 90 | 0 |
| K031954 | COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEM | New Star Lasers, Inc. | 2003-08-21 | 57 | 0 |
| K024259 | PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 | New Star Lasers, Inc. | 2003-06-20 | 179 | 0 |
| K031184 | COOL TOUCH 3 | New Star Lasers, Inc. | 2003-05-21 | 36 | 0 |
| K030453 | COOLTOUCH ND: YAG LASER SYSTEM | New Star Lasers, Inc. | 2003-05-12 | 90 | 0 |
| K023962 | NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-1 | New Star Lasers, Inc. | 2002-12-24 | 25 | 0 |
| K012982 | COOLTOUCH VARIZOOM | New Star Lasers, Inc. | 2001-10-02 | 27 | 0 |
| K002347 | COOLTOUCH II | New Star Lasers, Inc. | 2000-08-17 | 15 | 0 |
| K994273 | MODEL 1000 HOLMIUM LASER SYSTEM | New Star Lasers, Inc. | 2000-01-20 | 31 | 0 |
| K980607 | DERMATHERM 100 | New Star Lasers, Inc. | 1998-04-03 | 45 | 0 |
| K973764 | TEMPERATURE DIAGNOSTIC ACCESSORY | New Star Lasers, Inc. | 1997-12-31 | 90 | 0 |
| K962791 | NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM | New Star Lasers, Inc. | 1997-03-13 | 239 | 0 |
| K952489 | 6 WATT HOLMIUM LASER SYSTEM | New Star Lasers, Inc. | 1996-01-22 | 237 | 0 |
| K945156 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | New Star Lasers, Inc. | 1995-03-09 | 139 | 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