Product Code: PUL FDA class 2 21 CFR 886.4100

Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Ophthalmic

The Apparatus, Cutting, Radiofrequency, Electrosurgical, AC-Powered is an ophthalmic surgical device that uses radiofrequency energy to perform anterior capsulotomy during cataract surgery, creating a precise opening in the anterior lens capsule to facilitate lens removal and intraocular lens implantation. It is classified as FDA Class II under regulation 21 CFR 886.4100, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PUL and it falls under the Ophthalmic medical specialty. It is not flagged as an implant or life-sustaining device.

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510(k)s

FEI Numbers

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Basic Information

Product Code: PUL
Device Class: FDA class 2
Regulation Number: 886.4100
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

Used to perform anterior capsulotomy during cataract surgery

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K223763	ZeptoLink IOL Positioning System	Apr 11, 2023	Substantially Equivalent	Centricity Vision, Inc.
K221188	ZEPTO Precision Capsulotomy System	Jun 23, 2022	Substantially Equivalent	Centricity Vision, Inc.
K210827	ZEPTO Precision Capsulotomy System	Dec 14, 2021	Substantially Equivalent	Centricity Vision, Inc.
K170655	Zepto	Jun 02, 2017	Substantially Equivalent	Mynosys Cellular Devices, Inc.