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510(k) K827819

LASER PHOTOCOAGULATOR by American Laser Corp.

K827819 is an FDA 510(k) premarket notification submitted by American Laser Corp. for the device "LASER PHOTOCOAGULATOR". The FDA issued a decision of Substantially Equivalent on January 7, 1983. American Laser Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1983
Date Received
October 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by American Laser Corp.

  • K010046 — NUVOLASE 532 MEDICAL LASER SYSTEM (April 5, 2001)
  • K990665 — BQ/BM INTEGRATED LASER DELIVERY SYSTEM (May 17, 1999)
  • K990725 — NUVOLASE 532 LASER SYSTEM (March 22, 1999)
  • K813429 — LASER PHOTOCOAGULATOR ARGON MED. LASER (January 22, 1982)

FDA data resources