Last synced on 25 November 2022 at 11:04 pm

Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Page Type
Product Code
Definition
Used to perform anterior capsulotomy during cataract surgery
Physical State
RF power console and handpiece. The handpiece has the cutting element that delivers energy for capsulotomy.
Technical Method
A corneal incision is made into the anterior chamber of the eye. A cutting element is inserted through the incision and centered on the lens capsule. Energy is directed to the cutting element, creating the capsulotomy. The cutting element is removed from the anterior chamber.
Target Area
Cornea of the eye
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.4100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4100 Radiofrequency electrosurgical cautery apparatus

§ 886.4100 Radiofrequency electrosurgical cautery apparatus.

(a) Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

(b) Classification. Class II.

Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Page Type
Product Code
Definition
Used to perform anterior capsulotomy during cataract surgery
Physical State
RF power console and handpiece. The handpiece has the cutting element that delivers energy for capsulotomy.
Technical Method
A corneal incision is made into the anterior chamber of the eye. A cutting element is inserted through the incision and centered on the lens capsule. Energy is directed to the cutting element, creating the capsulotomy. The cutting element is removed from the anterior chamber.
Target Area
Cornea of the eye
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.4100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4100 Radiofrequency electrosurgical cautery apparatus

§ 886.4100 Radiofrequency electrosurgical cautery apparatus.

(a) Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

(b) Classification. Class II.