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510(k) K813492

BRITT KRYPTON LASERS 150K & 152K by Britt Corp., Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1982
Date Received
December 11, 1981
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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  • K860278 — MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC (April 15, 1986)
  • K851425 — MODEL J25-25 WATT CO2 LASER (November 12, 1985)

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