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510(k) K820280

SPECTRA 305/350 by Ultralite — Product Code KGL

K820280 is an FDA 510(k) premarket notification submitted by Ultralite for the device "SPECTRA 305/350". The FDA issued a decision of Substantially Equivalent on March 5, 1982. The device falls under product code KGL (Cabinet, Phototherapy (Puva)), a Class II device regulated under 21 CFR 878.4630. Ultralite has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1982
Date Received
February 2, 1982
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 Ultralite

  • K910091 — ULTRALITE PANELITE (May 30, 1991)
  • K861963 — ULTRALITE HF1236 HAND AND FOOT SYSTEM (June 25, 1986)
  • K820492 — SPECTRA305 (March 31, 1982)
  • K827123 — SPECTRA (ULTRAVIOLET PRODUCTS) (March 5, 1982)
  • K761179 — PSORALITE (May 3, 1977)

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)
  • 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