Device classification

Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Ophthalmic · 21 CFR 886.4100

Class IIProduct code PUL
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
PUL
Review panel
OP
Medical specialty
OP
Device name
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
Medical specialty description
Ophthalmic
Device class
2
Definition
Used to perform anterior capsulotomy during cataract surgery
Regulation number
886.4100
Implant flag
N
Submission type ID
1
Harmonized identifiers (openFDA)
K number
K221188, K223763, K210827, K170655
Registration number
3011398014, 2030624, 3009746061, 9681572
FEI number
3011398014, 3009746061, 3003263857, 3000206435
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.