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510(k) K780345

PHOTOCOAGULATOR LASER by Cavitron Corp. — Product Code HQB

K780345 is an FDA 510(k) premarket notification submitted by Cavitron Corp. for the device "PHOTOCOAGULATOR LASER". The FDA issued a decision of Substantially Equivalent on May 9, 1978. The device falls under product code HQB (Photocoagulator And Accessories), a Class II device regulated under 21 CFR 886.4690. Cavitron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1978
Date Received
March 1, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photocoagulator And Accessories
Device Class
Class II
Regulation Number
886.4690
Review Panel
OP
Submission Type

Other clearances by Cavitron Corp.

  • K811582 — THE PLACER (July 28, 1981)
  • K810207 — MINOR SURGERY LIGHT (February 13, 1981)
  • K802928 — SPIROMETRIC COMPUTER #SC-10 (December 17, 1980)
  • K801623 — CAVITRON ULTRASONIC SURG. ASPIR. CUSA (November 18, 1980)
  • K801877 — SLIT LAMP ATTACHMENT (September 16, 1980)
  • K800869 — MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA (May 28, 1980)
  • K800722 — AUTO-FIELD D AUTOMATED VISUAL DETECTOR (April 29, 1980)
  • K791585 — MODEL G-61 ULTRASONIC DENTAL UNIT (September 19, 1979)
  • K791277 — MODEL 6500 EXTRACTION IRRIGATION SYS (August 22, 1979)
  • K782054 — LASER, CO2 SURGICAL (January 17, 1979)

Other clearances for product code HQB

  • K220263 — Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex S (November 3, 2022)
  • K191846 — MAXReach Laser Probe (December 23, 2019)
  • K182646 — Vitreq disposable laser probes, light fibers and Chandelier (May 1, 2019)
  • K132614 — PEREGRINE CURVED ILLUMINATING LASER PROBE (November 14, 2013)
  • K122997 — 23GA CURVED ILLUMINATING LASER PROBE (June 26, 2013)
  • K122905 — PEREGRINE 23GA CURVED LASER PROBE (April 30, 2013)
  • K113857 — SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE (April 23, 2012)
  • K110951 — 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VAL (October 17, 2011)
  • K111493 — NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI (July 27, 2011)
  • K110228 — NIDEK MULTICOLOR LASER PHOTOCOAGULATOR (February 23, 2011)

FDA data resources