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510(k) K852575

WALDMANN F85/100W PUVA by Sylvania Lighting Products — Product Code KGL

K852575 is an FDA 510(k) premarket notification submitted by Sylvania Lighting Products for the device "WALDMANN F85/100W PUVA". The FDA issued a decision of Substantially Equivalent (with conditions) on August 16, 1985. The device falls under product code KGL (Cabinet, Phototherapy (Puva)), a Class II device regulated under 21 CFR 878.4630. Sylvania Lighting Products has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
August 16, 1985
Date Received
June 18, 1985
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 Sylvania Lighting Products

  • K852684 — WALDMANN F85/100W UV21 (July 11, 1985)
  • K852321 — SYLVANIA F8T5/PUVA & WALDMANN F15T8/PUVA (July 11, 1985)
  • K852576 — WALDMANN F85/100W UV6 (July 11, 1985)

Other clearances for product code KGL

  • 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)
  • K761094 — UVA PHOTOTHERAPY SYSTEM (December 2, 1976)

FDA data resources