← FDA Medical Device Classifications

Lacrimal Stents And Intubation Sets

OKS · Unclassified · Unknown

Classification

FDA Product Code
OKS
Device class
Unclassified
Regulation
Review panel
OP
Medical specialty
Unknown
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Definition

Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.

Market data

Cleared 510(k) submissions
31
Registered establishments
21

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown