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510(k) K905453

CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND by Douglas James Donaldson Compliance Services — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1991
Date Received
December 5, 1990
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

Other clearances by Douglas James Donaldson Compliance Services

  • K912987 — CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE (October 28, 1991)
  • K912284 — BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF (August 19, 1991)
  • K905115 — BIOVISION ENDOCULAR PROBE (February 11, 1991)
  • K904366 — CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR (October 19, 1990)

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