← FDA Medical Device Classifications

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

LOI · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code
LOI
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
Review panel
OP
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
1
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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