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510(k) K851425

MODEL J25-25 WATT CO2 LASER by Britt Corp., Inc. — Product Code HHR

K851425 is an FDA 510(k) premarket notification submitted by Britt Corp., Inc. for the device "MODEL J25-25 WATT CO2 LASER". The FDA issued a decision of Substantially Equivalent on November 12, 1985. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Britt Corp., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
April 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Surgical, Gynecologic
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
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)
  • K860277 — MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT (May 6, 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)
  • K840036 — FITEX (October 26, 1984)

Other clearances for product code HHR

  • K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (April 27, 1989)
  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (August 22, 1988)
  • K875314 — GL-35 COLPOSCOPIC LASER SYSTEM (August 5, 1988)
  • K874615 — LASER CANNISTER FILTER (June 23, 1988)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (June 1, 1988)
  • K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (May 31, 1988)
  • K880991 — LASER OPTICAL CATHETER SYSTEM (May 25, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K874837 — KTP/532 LASER FOR OB-GYN USE (March 14, 1988)
  • K875078 — HERACURE LS 500 (February 22, 1988)

FDA data resources