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510(k) K761094

UVA PHOTOTHERAPY SYSTEM by Dermatron Corp. — Product Code KGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1976
Date Received
November 23, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, Phototherapy (Puva)
Device Class
Class II
Regulation Number
878.4630
Review Panel
SU
Submission Type

Other clearances by Dermatron Corp.

  • K770862 — BLACK LAMPS,F72T12/BL/HO (June 27, 1977)
  • K760471 — LAMP, FLOURESCENT BLACK, HIGH OUTPUT (September 15, 1976)
  • K760482 — SUNLAMP (F40-UVB & F20-UVB) (September 15, 1976)
  • K760519 — SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 (September 3, 1976)

Other clearances for product code KGL

  • K852575 — WALDMANN F85/100W PUVA (August 16, 1985)
  • K841795 — UV 8001K, PUVA 800, PUVA 180/200 1000 (August 30, 1984)
  • K820280 — SPECTRA 305/350 (March 5, 1982)
  • K810668 — HO-B-LITE VI UNIT (April 23, 1981)
  • K810358 — PHOTOTHERAPY LIGHT CHAMBER (March 20, 1981)
  • K791977 — PSORALITE MARK I (December 28, 1979)
  • K791116 — PSORALITE SERIES 30,000 (September 4, 1979)