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

SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.

K Number: K882908 · Decision Sep 30, 1988
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
51
Review Days
80

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Basic Information

Device Name
SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.
K Number
K882908
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
886.4390
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent
Applicant
Surgical Laser Technologies, Inc.
Date Received
July 12, 1988
Decision Date
September 30, 1988
Product Code
HQF
Advisory Committee
Ophthalmic
Review Advisory Committee
OP
Third Party
N

Classifications

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

Product Code Device Name
HQF Laser, Ophthalmic

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Other Clearances by Surgical Laser Technologies, Inc.

K Number Device Name
K042211 MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
K023624 SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921
K011409 SLT LASERPRO CTH HOLMIUM LASER SYSTEM
K010041 SLT DIFFUSER FIBER
K984018 HEMOSLEEVE, MODEL 4.0MM, 5.5MM
K983050 PNEUMATIC CUTTER SYSTEM
K981041 SLT BIPOLAR SHEATH
K972548 SLT CL MD CONTACT LASER SYSTEM
K980156 SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS
K960821 SLT FUMICH PROBE GUIDE
Search all 51 clearances from Surgical Laser Technologies, Inc. →