Dilator, Lachrymal
A Lachrymal Dilator is a thin, tapered ophthalmic instrument used to widen the lacrimal puncta and canaliculi to facilitate probing, irrigation, or intubation of the tear drainage system for diagnosis or treatment of nasolacrimal duct obstruction. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket notification. It carries product code HNW and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HNW
- Device Class
- FDA class 1
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K862070 | INTER-SHARP | Jun 17, 1986 | Substantially Equivalent | Intermedics Intraocular, Inc. |
| K841002 | LACHRYMAL PROBES-VARIOUS | May 09, 1984 | Substantially Equivalent | Premier Dental Products Co. |
| K812097 | KOI LACREMAL HOOK & DILATOR | Aug 18, 1981 | Substantially Equivalent | Koi, Inc. |
FEI Numbers
This FDA classification entry is associated with 135 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 136 registration numbers. Click on an entry to view related FDA registrations.