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510(k) K833274

DERMATOLOGY HANDPIECE-OPHTH LASER by Synemed, Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1983
Date Received
September 21, 1983
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 Synemed, Inc.

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  • K852936 — THE FIELDMASTER MODEL 275 (October 15, 1985)
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  • K828585 — OPTHALAS PHOTOCOAGULATOR (January 3, 1983)
  • K822853 — MODEL 200 SQUID (October 18, 1982)
  • K813282 — SYNEVAC VACUUM CURETTAGE SYSTEMS (December 14, 1981)
  • K811270 — SCOPE MASTER (September 8, 1981)

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