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510(k) K902920

TURBOTRON 20/20 by Prestige Manufacturing Snd Bhd — Product Code LYL

K902920 is an FDA 510(k) premarket notification submitted by Prestige Manufacturing Snd Bhd for the device "TURBOTRON 20/20". The FDA issued a decision of Substantially Equivalent on October 10, 1991. The device falls under product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses), a Class II device regulated under 21 CFR 886.5928. Prestige Manufacturing Snd Bhd has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1991
Date Received
July 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

Other clearances by Prestige Manufacturing Snd Bhd

  • K894499 — ARMOR, LATEX EXAMINATION GLOVES (September 21, 1989)

Other clearances for product code LYL

  • K211361 — 3N Contact Lenses Adjunct Cleaner (January 13, 2022)
  • K210300 — VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Clean (April 1, 2021)
  • K083757 — BPZ02 MULTIPURPOSE SOLUTION (November 18, 2009)
  • K021699 — AUTOLENS CLEANING AND DISINFECTING UNIT (December 16, 2002)
  • K022687 — AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (November 19, 2002)
  • K020802 — RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (May 31, 2002)
  • K994021 — CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION (February 22, 2000)
  • K991965 — PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES (October 1, 1999)
  • K982115 — LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY (January 13, 1999)
  • K974724 — SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS (March 2, 1998)

FDA data resources