Home / 510(k) Clearances / K970590

510(k) K970590

N/A by North American Technical Services Corp. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1997
Date Received
February 18, 1997
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 North American Technical Services Corp.

  • K974321 — HYDROTONE (June 22, 1998)
  • K970592 — N/A (June 13, 1997)
  • K961582 — EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 (November 8, 1996)
  • K953440 — ELLMAN LAPTRODE (August 29, 1995)
  • K944558 — ELLMAN VAPOR-VAC II (April 28, 1995)
  • K944730 — MASSAGER (February 14, 1995)
  • K932204 — E-Z THERM 3 SECOND THERMOMETER (October 3, 1994)
  • K914364 — ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. (September 10, 1992)

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)