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510(k) K091962

POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 by Lumenis, Inc. — Product Code ODF

K091962 is an FDA 510(k) premarket notification submitted by Lumenis, Inc. for the device "POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200". The FDA issued a decision of Substantially Equivalent on September 30, 2009. The device falls under product code ODF (Mini Endoscope, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Lumenis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2009
Date Received
July 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mini Endoscope, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Lumenis, Inc.

  • K211979 — Lumenis Y&R Laser System (June 21, 2022)
  • K212703 — AcuPulse CO2 Laser System, Delivery Devices and Accessories (October 19, 2021)
  • DEN200028 — Lumenis Stellar M22 (February 23, 2021)
  • K203544 — UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accesso (December 24, 2020)
  • K202428 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (October 22, 2020)
  • K201663 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (July 16, 2020)
  • K193500 — Stellar M22 for Intense Pulsed Light (IPL) and Laser System (January 16, 2020)
  • K180597 — AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO (April 3, 2018)
  • K170179 — LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity (September 18, 2017)
  • K170060 — M22 and ResurFx Systems (August 9, 2017)

Other clearances for product code ODF

  • K092739 — MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DU (January 12, 2010)
  • K090170 — SPYSCOPE ACCESS AND DELIVERY CATHETER (February 4, 2009)
  • K052194 — SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR (August 24, 2005)
  • K050403 — SPYGLASS DIRECT VISULATION PROBE (March 4, 2005)
  • K963354 — 5 STAR MEDICAL ENDOSCOPE (September 8, 1997)
  • K943593 — SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM (March 22, 1995)
  • K941230 — MINI-UB ENDOSCOPES (June 17, 1994)
  • K933106 — ENDOSCOPE (October 19, 1993)
  • K912089 — MODIFIED SERIES 2100 ENDOSCOPES (August 12, 1991)
  • K910732 — CANDELA MINI-UB ENDOSCOPE (April 12, 1991)

FDA data resources