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510(k) K820492

SPECTRA305 by Ultralite — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1982
Date Received
February 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Ultraviolet, Dermatological
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)
  • K827123 — SPECTRA (ULTRAVIOLET PRODUCTS) (March 5, 1982)
  • K820280 — SPECTRA 305/350 (March 5, 1982)
  • K761179 — PSORALITE (May 3, 1977)

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