Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coherent Medical Group · Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
309 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963339 | COHERENT ULTRAPULSE CO2 SURGICAL LASERS | Coherent Medical Group | 1997-01-22 | 149 | 0 |
| K960032 | COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS | Coherent Medical Group | 1996-04-01 | 90 | 0 |
| K932981 | COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERS | Coherent Medical Group | 1994-05-02 | 318 | 0 |
| K923575 | COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERS | Coherent Medical Group | 1993-09-29 | 436 | 0 |
| K932468 | NOVUS MULTIWAVELENGTH | Coherent Medical Group | 1993-09-22 | 121 | 0 |
| K930981 | ACCULITE(TM) OTOPROBE | Coherent Medical Group | 1993-07-28 | 153 | 0 |
| K914136 | COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE | Coherent Medical Group | 1992-07-21 | 309 | 0 |
| K914991 | VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS | Coherent Medical Group | 1992-05-06 | 181 | 0 |
| K913127 | COHERENT NOVUS 3000 ARGON PHOTOCOAGULATOR | Coherent Medical Group | 1991-10-08 | 85 | 0 |
| K910037 | COHERENT HOLMIUM:YAG SURGICAL LASER | Coherent Medical Group | 1991-09-25 | 264 | 0 |
| K912029 | ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER | Coherent Medical Group | 1991-08-13 | 98 | 0 |
| K893709 | COHERENT MARIE ARGON PHOTOCOAGULATOR | Coherent Medical Group | 1989-06-15 | 28 | 0 |
| K885196 | LASER INDIRECT OPHTHALMOSCOPE (LIO) | Coherent Medical Group | 1989-01-11 | 26 | 0 |
| K880603 | COHERENT XA-40 CO2 SURGICAL LASER | Coherent Medical Group | 1988-03-11 | 28 | 0 |
| K874811 | MODEL 5202 MICROMANIPULATOR | Coherent Medical Group | 1988-02-05 | 77 | 0 |
| K874648 | COHERENT XA-30/SP CO2 SURGICAL LASER | Coherent Medical Group | 1988-02-04 | 83 | 0 |
| K873760 | SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER | Coherent Medical Group | 1987-11-27 | 72 | 0 |
| K873246 | MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2 | Coherent Medical Group | 1987-11-10 | 88 | 0 |
| K873963 | COHERENT XA-30 CO2 SURGICAL LASER | Coherent Medical Group | 1987-10-19 | 20 | 0 |
| K870161 | MODEL 5000 MICROMANIPULATOR MICRO CO2 LASER SYSTEM | Coherent Medical Group | 1987-04-14 | 91 | 0 |
| K870517 | 0.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE | Coherent Medical Group | 1987-04-10 | 64 | 0 |
| K862568 | LDS - LASER DELIVERY SYSTEM | Coherent Medical Group | 1986-10-07 | 92 | 0 |
| K852860 | MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE | Coherent Medical Group | 1985-10-07 | 91 | 0 |
| K852190 | MODEL 451 CO2 SURGICAL LASER | Coherent Medical Group | 1985-08-23 | 93 | 0 |
| K844357 | SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR | Coherent Medical Group | 1985-06-05 | 208 | 0 |
| K844356 | SYSTEM 930 ARGON PHOTOCOAGULATOR | Coherent Medical Group | 1985-05-16 | 188 | 0 |
| K844358 | SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP | Coherent Medical Group | 1985-01-03 | 55 | 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