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510(k) K841795

UV 8001K, PUVA 800, PUVA 180/200 1000 by Waldmann Lighting Co. — Product Code KGL

K841795 is an FDA 510(k) premarket notification submitted by Waldmann Lighting Co. for the device "UV 8001K, PUVA 800, PUVA 180/200 1000". The FDA issued a decision of Substantially Equivalent on August 30, 1984. The device falls under product code KGL (Cabinet, Phototherapy (Puva)), a Class II device regulated under 21 CFR 878.4630. Waldmann Lighting Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1984
Date Received
May 2, 1984
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 Waldmann Lighting Co.

  • K053364 — HALUX IRIS EXAMINATION AND SURGICAL LAMP (February 23, 2006)

Other clearances for product code KGL

  • K852575 — WALDMANN F85/100W PUVA (August 16, 1985)
  • 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