Home / 510(k) Clearances / K852684

510(k) K852684

WALDMANN F85/100W UV21 by Sylvania Lighting Products — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1985
Date Received
June 25, 1985
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 Sylvania Lighting Products

  • K852575 — WALDMANN F85/100W PUVA (August 16, 1985)
  • K852321 — SYLVANIA F8T5/PUVA & WALDMANN F15T8/PUVA (July 11, 1985)
  • K852576 — WALDMANN F85/100W UV6 (July 11, 1985)

Other clearances for product code FTC

  • K253871 — Klär Lite (RCW-KL1000) (March 4, 2026)
  • K250425 — Ultraviolet Phototherapy Device (April 7, 2025)
  • K244022 — 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm (March 13, 2025)
  • K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-50 (February 6, 2025)
  • K242908 — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, (December 19, 2024)
  • K233811 — DT Controlled Phototherapy Equipment (December 13, 2023)
  • K223882 — Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) (March 27, 2023)
  • K230382 — 3 Series NeoLux (March 24, 2023)
  • K230076 — Enhanced AURORA™ Medical Diode System, and related accessories (March 8, 2023)
  • K220840 — 1 Series Phototherapy Equipment (April 22, 2022)