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510(k) K041679

COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT by Onyx Medical, Inc. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2004
Date Received
June 21, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

Other clearances by Onyx Medical, Inc.

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  • K931680 — CANNULATED CANCELLOUS SCREW (May 4, 1994)
  • K931684 — EPIPHYSIS PLATE (May 4, 1994)
  • K934614 — MINI FRAGMENT PLATE (May 4, 1994)
  • K931687 — MULTIPLE FRAGMENT PLATE (April 25, 1994)
  • K931685 — FOREARM SELF COMPRESSION PLATE (April 25, 1994)
  • K931688 — SEMI-TUBULAR PLATE (April 25, 1994)
  • K931691 — STRAIGHT MINI-PLATE (April 25, 1994)

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