510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843345Substantially Equivalent

Agl400 Argon Laser System-Krl500 Krypton

Mira, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843345 is the FDA 510(k) clearance record for AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON, cleared for Mira, Inc. on . FDA records list 19 510(k) clearances for Mira, Inc., from to . As of , FDA records show no recalls naming K843345.

Clearance record

Decision date
Received
(71 days to decision)
Review panel
Unknown
Applicant
Mira, Inc. 87 Rumford Ave., Waltham MA
Third party review
No