Device classification

Maxwell Spot, Ac-Powered

Ophthalmic · 21 CFR 886.1435

Class IProduct code HIXExempt
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
HIX
Review panel
OP
Medical specialty
OP
Device name
Maxwell Spot, Ac-Powered
Medical specialty description
Ophthalmic
Device class
1
Regulation number
886.1435
Implant flag
N
Submission type ID
4
Harmonized identifiers (openFDA)
K number
K831829, K801554
Registration number
3009973336
FEI number
3009973336
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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.