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510(k) K855093

MEDILAS 2 ND:YAG LASER SURGERY SYSTEM by Endo Lase, Inc. — Product Code HHR

K855093 is an FDA 510(k) premarket notification submitted by Endo Lase, Inc. for the device "MEDILAS 2 ND:YAG LASER SURGERY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 21, 1986. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Endo Lase, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1986
Date Received
December 20, 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 Endo Lase, Inc.

  • K853900 — ENDO-LASE CD40 FOR NEUROSURGERY (June 18, 1986)
  • K853878 — ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY (May 2, 1986)
  • K853876 — ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY (February 21, 1986)
  • K853903 — ENDO-LASE CD40 CO2 FOR GYNECOLOGY (February 21, 1986)
  • K853877 — ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY (February 19, 1986)
  • K853901 — ENDO-LASE CD 40 FOR DERMATOLOGY (February 19, 1986)
  • K853580 — MEDILAS 2 (February 13, 1986)
  • K860152 — MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY (February 5, 1986)
  • K853875 — ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY (January 9, 1986)
  • K853902 — ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY (January 9, 1986)

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