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510(k) K792083

HAAG-STREIT SLIT LAMP 900 by Lumenis, Inc. — Product Code HRM

K792083 is an FDA 510(k) premarket notification submitted by Lumenis, Inc. for the device "HAAG-STREIT SLIT LAMP 900". The FDA issued a decision of Substantially Equivalent on November 16, 1979. The device falls under product code HRM (Microscope, Operating & Accessories, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 878.4700. Lumenis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1979
Date Received
October 16, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

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 HRM

  • K932720 — HM-0970 (September 7, 1993)
  • K930439 — MARCO SURGISCOPE OPERATION MICROSCOPES (July 22, 1993)
  • K920641 — ALCON OPERATING MICROSCOPES (October 9, 1992)
  • K914956 — KEELER KONAN SPECULAR MICROSCOPE SP5500 (February 3, 1992)
  • K891584 — S 22 INSTRUMENT STAND (June 8, 1989)
  • K891001 — MICROSCOPE KNOB COVER, STERILE, DISPOSABLE (April 11, 1989)
  • K854440 — MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 (December 16, 1985)
  • K853855 — XTAL X-150 OPERATING MICROSCOPE (October 15, 1985)
  • K852586 — CROMIC SURGICAL MICROSCOPE MODEL MC-1 (July 30, 1985)
  • K852150 — CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 (June 3, 1985)

FDA data resources