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510(k) K810668

HO-B-LITE VI UNIT by National Biological Corp. — Product Code KGL

K810668 is an FDA 510(k) premarket notification submitted by National Biological Corp. for the device "HO-B-LITE VI UNIT". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code KGL (Cabinet, Phototherapy (Puva)), a Class II device regulated under 21 CFR 878.4630. National Biological Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1981
Date Received
March 12, 1981
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 National Biological Corp.

  • K070934 — PANOSOL II TRU-BLU, MODEL UBL-417 (May 22, 2007)
  • K041212 — HOUVA 3 PHOTOTHERAPY SYSTEM (June 9, 2004)
  • K982082 — HANDISOL WOUND HEALING (October 28, 1998)
  • K934808 — UVISOL AND UVISOL II (December 16, 1993)
  • K924969 — PHOTOTHERAPY TIMER (February 23, 1993)
  • K924077 — HANDISOL (November 20, 1992)
  • K904428 — PANOSOL II UAB-228 (December 24, 1990)
  • K904426 — PANOSOL II UVA-218 (December 24, 1990)
  • K904427 — PANOSOL II UVB-206 (December 24, 1990)
  • K885026 — HOUVA II UVB (June 2, 1989)

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)
  • 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