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510(k) K902263

OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION by Trimedyne, Inc. — Product Code GGX

K902263 is an FDA 510(k) premarket notification submitted by Trimedyne, Inc. for the device "OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION". The FDA issued a decision of Substantially Equivalent on July 23, 1990. The device falls under product code GGX (Pipette, Sahli), a Class I device regulated under 21 CFR 864.6160. Trimedyne, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1990
Date Received
May 21, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pipette, Sahli
Device Class
Class I
Regulation Number
864.6160
Review Panel
HE
Submission Type

Other clearances by Trimedyne, Inc.

  • K053457 — VAPORMAX II (December 21, 2005)
  • K050412 — VAPORMAX (March 14, 2005)
  • K043012 — OMNIPULSE MINI, MODEL 2120 (November 17, 2004)
  • K041660 — TRIMEDYNE HOLMIUM LASER SYSTEMS (September 8, 2004)
  • K022655 — TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH (November 7, 2002)
  • K013974 — RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A (September 23, 2002)
  • K002308 — OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, (December 20, 2000)
  • K001676 — OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, (November 2, 2000)
  • K992574 — OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MO (October 29, 1999)
  • K992230 — OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP (July 12, 1999)

Other clearances for product code GGX

  • K894389 — CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS (October 12, 1989)

FDA data resources