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510(k) K921633

ORS-2000 SERIES by Mnlase, Inc. — Product Code LHC

K921633 is an FDA 510(k) premarket notification submitted by Mnlase, Inc. for the device "ORS-2000 SERIES". The FDA issued a decision of Substantially Equivalent on June 2, 1992. The device falls under product code LHC (Warmer, Irrigation Solution), a Class I device regulated under 21 CFR 890.5950. Mnlase, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1992
Date Received
April 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Irrigation Solution
Device Class
Class I
Regulation Number
890.5950
Review Panel
HO
Submission Type

Other clearances by Mnlase, Inc.

  • K944630 — MODEL 230-SAS LASER DELIVERY PROBE (November 9, 1994)
  • K944629 — MODEL 230-SAC LASER DELIVERY PROBE (November 3, 1994)
  • K944471 — STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE (November 3, 1994)
  • K944470 — CURVED ENDOPHOTOCOAGULATOR LASER PROBE (November 3, 1994)
  • K944625 — MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER (November 3, 1994)
  • K944628 — MODEL 220-SS LASER DELIVERY PROBE (November 3, 1994)
  • K944626 — MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER (November 3, 1994)
  • K944627 — MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER (November 3, 1994)
  • K944624 — MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER (November 1, 1994)
  • K944282 — LASER DELIVERY PROBE (November 1, 1994)

Other clearances for product code LHC

  • K153713 — Getinge Series Warming Cabinet (June 7, 2016)
  • K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (January 15, 2016)
  • K150190 — IntraTemp Solution Warmer (February 26, 2015)
  • K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (December 30, 2014)
  • K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE (August 28, 2014)
  • K083417 — INTRATEMP SOLUTION WARMER (January 13, 2009)
  • K080609 — SWC/DWC WARMING CABINETS (June 13, 2008)
  • K051819 — C CHANGE SOLUTION WARMER (August 15, 2005)
  • K023283 — 1075LD HUSH-SLUSH (November 13, 2002)
  • K023282 — ORS-3000LD (November 13, 2002)

FDA data resources