510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Coherent, Inc.

Santa Clara, CA

Coherent, Inc. appears in FDA device records in Santa Clara, CA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
3
Registered establishments
0

FDA records under these names

1 name

FDA records resolved to Coherent, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Coherent Inc Laser Grouprecall

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

No FDA product codes recorded against this company.

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0360-04Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine.Software problem that may cause unintended emission of laser radiation.Terminated
Z-0540-04Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. The following Model---Serial Numbers (S/N) are affected: P/N 1024403---S/Ns 10026 Through 10088; P.V. -4240/4475---S/Ns 2, 7, 3053, and 10002 through 10024; and P. V. -4458 S/Ns 10019, 10019, 10020, 10043, and 10052.Software problem that may cause unintended emission of laser radiation.Terminated
Z-0357-04Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers: TFAP0004P--TFAP00048Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain