Laser, Ophthalmic

Device Code: 4295

Product Code(s): HQF

Device Classification Information

Device Type ID4295
Device NameLaser, Ophthalmic
Regulation DescriptionOphthalmic Laser.
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Contact Lenses And Retinal Devices Branch (CLRD)
Submission Type510(k)
CFR Regulation Number886.4390 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHQF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID4295
DeviceLaser, Ophthalmic
Product CodeHQF
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionOphthalmic Laser.
CFR Regulation Number886.4390 [🔎]
Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC INC
 
SUBSTANTIALLY EQUIVALENT
1
CARL ZEISS MEDITEC, INC.
 
SUBSTANTIALLY EQUIVALENT
1
ELLEX MEDICAL PTY. LTD.
 
SUBSTANTIALLY EQUIVALENT
1
ELLEX, INC.
 
SUBSTANTIALLY EQUIVALENT
1
KATALYST SURGICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
1
LIGHTMED CORP.
 
SUBSTANTIALLY EQUIVALENT
1
LIGHTMED CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
LUTRONIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
LUTRONIC, INC.
 
SUBSTANTIALLY EQUIVALENT
1
NIDEK CO
 
SUBSTANTIALLY EQUIVALENT
3
NIDEK CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
2
OPHTHALMED LLC
 
SUBSTANTIALLY EQUIVALENT
1
QUANTEL MEDICAL
 
SUBSTANTIALLY EQUIVALENT
2
TOPCON MEDICAL LASER SYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
2
Device Problems
Laser
55
Device Operates Differently Than Expected
30
Adverse Event Without Identified Device Or Use Problem
29
Device Operational Issue
19
System
16
Unexpected Therapeutic Results
15
Failure To Deliver Energy
12
Probe
9
Insufficient Information
9
Misfocusing
8
Output Problem
8
Energy Output Problem
7
Failure To Fire
7
Power Problem
6
Output Below Specifications
6
Loss Of Power
6
Device Displays Incorrect Message
5
Self-Activation Or Keying
4
Appropriate Term/Code Not Available
4
Device Inoperable
4
Defective Component
3
Operating System Becomes Nonfunctional
3
Switches
3
Component Or Accessory Incompatibility
3
Protective Measures Problem
2
Material Separation
2
Calibration Problem
2
Nonstandard Device
2
Overheating Of Device
2
Inadequate User Interface
2
Energy Output To Patient Tissue Incorrect
2
Difficult To Remove
1
Sparking
1
Improper Device Output
1
Improper Or Incorrect Procedure Or Method
1
Application Interface Becomes Non-Functional Or Program Exits Abnormally
1
Continuous Firing
1
Output Above Specifications
1
No Display / Image
1
Inadequate Instructions For Healthcare Professional
1
Smoking
1
Use Of Device Problem
1
Suction Problem
1
Physical Property Issue
1
No Apparent Adverse Event
1
Failure To Align
1
Defective Device
1
Failure To Shut Off
1
Temperature Problem
1
Knife
1
Computer Software Problem
1
Manufacturing, Packaging Or Shipping Problem
1
Inadequate Or Insufficient Training
1
Application Program Problem
1
Use Of Incorrect Control Settings
1
Environmental Particulates
1
Installation-Related Problem
1
Device Handling Problem
1
Monitor
1
Fitting Problem
1
Total Device Problems 314
Recalls
Manufacturer Recall Class Date Posted
1
Bausch & Lomb Inc
II Dec-23-2014
2
Carl Zeiss Meditec AG
II Mar-07-2014
3
Laserex Systems Inc.
II Apr-07-2016
4
Lumenis, Inc.
II Sep-30-2014
5
Nidek Inc
II Feb-19-2015
6
Nidek Inc
II Nov-17-2014
7
Nidek Inc
II Nov-17-2014
8
Nidek Inc
II Jul-30-2014
9
Topcon Medical Laser Systems, Inc
II Aug-11-2016
10
Ziemer Usa Inc
II Jan-15-2015
11
Ziemer Usa Inc
II Jan-23-2014
TPLC Last Update: 2019-04-02 20:46:24

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