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510(k) K951829

COLD LIGHT SOURCE LOS 150 by Laser-Optik-Systeme GmbH & Co. KG — Product Code EQH

K951829 is an FDA 510(k) premarket notification submitted by Laser-Optik-Systeme GmbH & Co. KG for the device "COLD LIGHT SOURCE LOS 150". The FDA issued a decision of Substantially Equivalent on July 10, 1995. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Laser-Optik-Systeme GmbH & Co. KG has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1995
Date Received
April 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Carrier, Fiberoptic Light
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
Submission Type

Other clearances by Laser-Optik-Systeme GmbH & Co. KG

  • K972056 — STANDARD ENDOSCOPE (July 30, 1997)
  • K950712 — PORTABLE ENDOSCOPY SYSTEM (May 14, 1996)
  • K952028 — COLD LIGHT SOURCE LOS XL-A 100 (July 27, 1995)

Other clearances for product code EQH

  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K934911 — SAPHIRE PLUS SURGICAL MIRROR (June 21, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)
  • K923227 — THROAT-A-SCOPE (December 4, 1992)

FDA data resources