FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE

K Number: K873571 · Decision Nov 6, 1987
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
5
Review Days
65

Basic Information

Device Name
LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE
K Number
K873571
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4810
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
LASERGUIDE
Date Received
September 2, 1987
Decision Date
November 6, 1987
Product Code
GEX
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GEX Powered Laser Surgical Instrument

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K Number Device Name
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K875104 SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE
K873664 LIGHT-SPOT FIBEROPTIC LASER HANDPIECE