BIOINSULATED SILICONE PUNCTUM PLUG
FDA 510(k) clearance K001234 · decided 2000-07-11
Clearance details
- K-number
- K001234
- Device name
- BIOINSULATED SILICONE PUNCTUM PLUG
- Applicant
- Advanced Vision Science
- Decision
- Substantially Equivalent
- Date received
- 2000-04-17
- Decision date
- 2000-07-11
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- LZU
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Goleta, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Advanced Vision Science
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Hello,eyes® BIO Plug (K241229) | Bio Optics Co., Ltd. | 2024-06-28 |
| Visant Medical Canalicular Plug (K222164) | Visant Medical, Inc. | 2022-12-23 |
| SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (K213988) | Oasis Medical, Inc. | 2022-06-03 |
| Tear Pool Dissolvable Punctum Plugs (K190210) | Alphamed, Inc. | 2019-10-24 |
| Soft Plug Extended Duration 180 Canalicular Plug (K162361) | Oasis Medical, Inc. | 2017-04-17 |
| LacriPro Punctum Plug (K161673) | Lacrimedics, Inc. | 2016-11-18 |
| PDO Absorbable Punctum Plug (K150288) | Riverpoint Medical | 2015-08-28 |
| VERAPLUG (K140352) | Krishna Imports Inc Dba Stephens Instruments | 2014-11-13 |
| COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG, (K140711) | Paragon Bioteck, Inc. | 2014-06-20 |
| COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (K140026) | Lacrimedics, Inc. | 2014-06-03 |
| FLOW CONTROLLER (K090938) | Odyssey Medical, Inc. | 2009-06-04 |
| SNUG PLUG PUNCTUM PLUG (K061398) | Fci Ophthalmics, Inc. | 2006-07-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SINGLE-PIECE AND THREE PIECE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) (P830033/S027) | Advanced Vision Science | 1996-01-29 |
| MODELS PCUB-30SEO AND PCUB-32SEO IOL (P830033/S026) | Advanced Vision Science | 1995-06-05 |
| TIER B MODEL SBUV20-23DO IOL (P830033/S025) | Advanced Vision Science | 1992-03-20 |
| MODEL 56BUV20-24DO IOL (P830033/S024) | Advanced Vision Science | 1991-10-07 |
| MODELS PCUB-32D0 AND PCUB-53D0 (P830033/S023) | Advanced Vision Science | 1991-05-28 |
| MODEL 5BUV20-24DO IOL (P830033/S022) | Advanced Vision Science | 1990-11-15 |
| SINGLE-PIECE UV-ABSORBING POSTERIOR CHAMBER IOLS (P830033/S021) | Advanced Vision Science | 1990-10-05 |
| SINGLE-PIECE UV-ABSORBING POSTERIOR CHAMBER IOLS (P830033/S018) | Advanced Vision Science | 1990-07-20 |