FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
K Number: K895342
·
Decision Nov 2, 1989
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
12
Review Days
63
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
- K Number
- K895342
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Lacrimedics, Inc.
- Date Received
- August 31, 1989
- Decision Date
- November 2, 1989
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZU), ordered by most recent decision date.
Hello,eyes® BIO Plug
FDA 510(k)
FDA Unclassified
·Unknown
Visant Medical Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
Tear Pool Dissolvable Punctum Plugs
FDA 510(k)
FDA Unclassified
·Unknown
Soft Plug Extended Duration 180 Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
LacriPro Punctum Plug
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Lacrimedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161673 | LacriPro Punctum Plug | Nov 18, 2016 | Substantially Equivalent |
| 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 |
| K890714 | LACRIMAL EFFICIENCY TEST (TM) | May 17, 1989 | Substantially Equivalent |