Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reliant Technologies, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
153 daysmedian FDA review time
203 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080915 | FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2008-07-01 | 90 | 0 |
| K071051 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2007-11-02 | 203 | 0 |
| K071621 | RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2007-10-09 | 117 | 0 |
| K070284 | FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) | Reliant Technologies, Inc. | 2007-05-17 | 108 | 0 |
| K063808 | FRAXEL IV SR LASER SYSTEM | Reliant Technologies, Inc. | 2007-04-27 | 126 | 0 |
| K063038 | FRAXEL III SR LASER SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2007-04-27 | 207 | 0 |
| K062303 | FRAXEL II SR LASER SYSTEM | Reliant Technologies, Inc. | 2007-01-31 | 176 | 0 |
| K060310 | FRAXEL II SR LASER SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2006-03-29 | 50 | 0 |
| K053047 | FRAXEL SR LASER SYSTEM | Reliant Technologies, Inc. | 2006-03-20 | 143 | 0 |
| K050841 | FRAXEL SR LASER SYSTEM | Reliant Technologies, Inc. | 2005-07-05 | 95 | 0 |
| K042319 | RELIANT LASER II SYSTEM AND ACCESSORIES | Reliant Technologies, Inc. | 2005-03-10 | 196 | 0 |
| K040617 | RELIANT LASER SYSTEM II | Reliant Technologies, Inc. | 2004-06-15 | 98 | 0 |
| K031795 | RELIANT LASER SYSTEM | Reliant Technologies, Inc. | 2003-11-10 | 153 | 0 |
| K023050 | RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT | Reliant Technologies, Inc. | 2003-02-14 | 154 | 0 |
| K971821 | UNICA 315 M CO2 SURGICAL LASER SYSTEM | Reliant Technologies, Inc. | 1997-09-25 | 132 | 0 |
| K953670 | ACCUSCAN MODEL C CO2 LASER SCANNER | Reliant Technologies, Inc. | 1996-01-26 | 172 | 0 |
| K944437 | DISPOSABLE LASER SWEEP TIP | Reliant Technologies, Inc. | 1995-03-14 | 183 | 0 |
| K942935 | ACUTOME 100 COLOR-CORRECTED CO2 LASER HANDPIECE | Reliant Technologies, Inc. | 1994-12-19 | 180 | 0 |
| K943045 | UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED | Reliant Technologies, Inc. | 1994-12-13 | 169 | 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