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510(k) K863246

MIRALITE by Mira, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1986
Date Received
August 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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  • K863591 — ENDOPHOTOCOAGULATION PROBE (October 10, 1986)
  • K855105 — SIMMONS SHELL (March 31, 1986)

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