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510(k) K791977

PSORALITE MARK I by Paul B. Elder Co. — Product Code KGL

K791977 is an FDA 510(k) premarket notification submitted by Paul B. Elder Co. for the device "PSORALITE MARK I". The FDA issued a decision of Substantially Equivalent on December 28, 1979. The device falls under product code KGL (Cabinet, Phototherapy (Puva)), a Class II device regulated under 21 CFR 878.4630. Paul B. Elder Co. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1979
Date Received
October 2, 1979
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 Paul B. Elder Co.

  • K810358 — PHOTOTHERAPY LIGHT CHAMBER (March 20, 1981)
  • K791116 — PSORALITE SERIES 30,000 (September 4, 1979)

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)
  • K791116 — PSORALITE SERIES 30,000 (September 4, 1979)
  • K761094 — UVA PHOTOTHERAPY SYSTEM (December 2, 1976)

FDA data resources