Last synced on 14 June 2024 at 11:05 pm

Computer Assisted Hair Harvesting System

Page Type
Product Code
Definition
A computer assisted harvesting system used in identifying and extracting hair follicular units and indicated to assist surgeon in identifying and extracting hair follicular units during hair transplantation.
Physical State
computer assisted station with needle mechanism, force sensor, robotic arm and video imaging system
Technical Method
computer assisted harvesting sysem
Target Area
scalp
Regulation Medical Specialty
Neurology
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 882.4560 Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).

Computer Assisted Hair Harvesting System

Page Type
Product Code
Definition
A computer assisted harvesting system used in identifying and extracting hair follicular units and indicated to assist surgeon in identifying and extracting hair follicular units during hair transplantation.
Physical State
computer assisted station with needle mechanism, force sensor, robotic arm and video imaging system
Technical Method
computer assisted harvesting sysem
Target Area
scalp
Regulation Medical Specialty
Neurology
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 882.4560 Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).