Home / 510(k) Clearances / K051681

510(k) K051681

DERMILLUME RED, MODEL HR1000 by Care Electronics, Inc. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2005
Date Received
June 23, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

Other clearances by Care Electronics, Inc.

  • K043575 — DERMILLUME, MODEL PRO1000 (February 24, 2005)
  • K925529 — WANDER CARE (June 16, 1993)

Other clearances for product code ILY

  • K242755 — Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CH (May 19, 2025)
  • K231997 — SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) (October 15, 2024)
  • K223642 — LED Lip Perfector, model: ZC-05 (March 9, 2023)
  • K221189 — OLIZ LTB-1000A (August 29, 2022)
  • K213524 — CytonPro-5000 (August 10, 2022)
  • K202028 — dermalux Flex MD (December 16, 2020)
  • K171087 — AXON IR Heat Lamp (July 7, 2017)
  • K163079 — HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM ( (June 13, 2017)
  • K170068 — Softcure 96 (May 5, 2017)
  • K162590 — Bashan TDP Heat Lamp (February 14, 2017)