FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
LacriPro Punctum Plug
K Number: K161673
·
Decision Nov 18, 2016
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
12
Review Days
155
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Basic Information
- Device Name
- LacriPro Punctum Plug
- K Number
- K161673
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lacrimedics, Inc.
- Date Received
- June 16, 2016
- Decision Date
- November 18, 2016
- Product Code
- LZU
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZU | Plug, Punctum | FDA unclassified | Unknown |
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Other Clearances by Lacrimedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140026 | COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST | Jun 3, 2014 | Substantially Equivalent |
| K030300 | OPAQUE HERRICK LACRIMAL PLUG | May 9, 2003 | Substantially Equivalent |
| K021831 | OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB | Jul 1, 2002 | Substantially Equivalent |
| K001737 | OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM | Jun 19, 2000 | Substantially Equivalent |
| K963708 | HERRICK ULTIMATE PUNCTUM PLUG | Apr 14, 1997 | Substantially Equivalent |
| K963501 | HERRICK ULTIMATE PUNCTUM PLUG | Apr 14, 1997 | Substantially Equivalent |
| K944402 | FOCOMETER | Nov 22, 1994 | Substantially Equivalent |
| K896175 | HERRICK LACRIMAL PLUG TM. | Jan 22, 1990 | Substantially Equivalent |
| K895342 | COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST | Nov 2, 1989 | Substantially Equivalent |
| K890714 | LACRIMAL EFFICIENCY TEST (TM) | May 17, 1989 | Substantially Equivalent |