Identity
- Trade Name
- Comfortear™ FDA UDI
- Generic Name
- Lacrimal punctum plug FDA UDI
- Device Name
- Comfortear™ Punctum Plug Inserter, 2 pkg FDA UDI
- Model / Reference
- 60-6010 FDA UDI
- Description
- Comfortear™ Punctum Plug Inserter, 2 pkg FDA UDI
Identifiers
- Catalog Number
- 60-6010 FDA UDI
- Primary DI / UDI-DI
- 10810003223644 FDA UDI
- 510(k) Number
- K050851 FDA UDI
- FDA Product Code
- LZU FDA UDI
- GMDN Term
- Lacrimal punctum plug FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDI
Category: Lacrimal punctum plug
Comfortear™ by Microspecialities, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lacrimal punctum plug.
- SuperFlex — Katena Products, Inc. · U
- Diamatrix — Diamatrix · U
- Lacrimal Plug — RIVERPOINT MEDICAL LLC · U
- Comfortear Lacrisolve 180 Absorbable Punctum Plug — RIVERPOINT MEDICAL LLC · U
- Diamatrix — Diamatrix · U
- SOFT PLUG® Silicone Punctum Plug — OASIS Medical, Inc. · U
- Stephens Instruments — KRISHNA IMPORTS INC · U
- Lacrivera — STEPHENS INSTRUMENTS, INC · Class IIb
Cleared under the same submission
K050851 also covers:
- Comfortear™ — MICROSPECIALITIES, INC.
- Comfortear™ — MICROSPECIALITIES, INC.
- Comfortear™ — MICROSPECIALITIES, INC.
- Comfortear™ — MICROSPECIALITIES, INC.
- Comfortear™ — MICROSPECIALITIES, INC.
- Comfortear™ — MICROSPECIALITIES, INC.
- Comfortear™ — MICROSPECIALITIES, INC.
- Comfortear™ — MICROSPECIALITIES, INC.
- Comfortear™ — MICROSPECIALITIES, INC.
- Comfortear™ — MICROSPECIALITIES, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microspecialities, Inc.
Sources (1)
- FDA UDI c2bc04ea-26dd-4b6e-bd55-bfdeec588988 37 fields · synced Jun 1, 2026