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510(k) K860277

MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT by Britt Corp., Inc. — Product Code EWG

K860277 is an FDA 510(k) premarket notification submitted by Britt Corp., Inc. for the device "MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT". The FDA issued a decision of Substantially Equivalent on May 6, 1986. The device falls under product code EWG (Laser, Ent Microsurgical Carbon-Dioxide), a Class II device regulated under 21 CFR 874.4500. Britt Corp., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1986
Date Received
January 27, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ent Microsurgical Carbon-Dioxide
Device Class
Class II
Regulation Number
874.4500
Review Panel
EN
Submission Type

Other clearances by Britt Corp., Inc.

  • K003828 — VASO PRESS DVT FOOT GARMENT #VP 520 (May 18, 2001)
  • K991038 — VASO PRESS DVT SYSTEM, MODELS VP500, VP501 (June 22, 2000)
  • K974393 — VASO PRESS SYSTEM (March 19, 1999)
  • K860977 — MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION (October 16, 1986)
  • K860975 — MODEL 545-45 LASER FOR EAR, NOSE & THROAT (July 18, 1986)
  • K860974 — MODEL 545-45 LASER FOR DERMA., POD., SURGICAL (July 7, 1986)
  • K860273 — MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY (April 23, 1986)
  • K860278 — MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC (April 15, 1986)
  • K851425 — MODEL J25-25 WATT CO2 LASER (November 12, 1985)
  • K840020 — FITNESS LOGGER (October 26, 1984)

Other clearances for product code EWG

  • K924652 — BENSON CCA100 (April 9, 1993)
  • K870587 — LASERMATIC SURGILASER MODEL 5050 (August 10, 1988)
  • K880429 — ILLUMINA 55 CO2 LASER SYSTEM (April 18, 1988)
  • K880428 — ILLUMINA 25 CO2 LASER SYSTEM (April 18, 1988)
  • K880427 — ILLUMINA 40 CO2 LASER SYSTEM (April 18, 1988)
  • K872710 — MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT (September 24, 1987)
  • K870840 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH (June 12, 1987)
  • K864975 — LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) (February 25, 1987)
  • K862866 — MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE (January 9, 1987)
  • K862865 — MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE (January 9, 1987)

FDA data resources