Identity
- Trade Name
- LASIK Spear FDA UDI
- Generic Name
- Ophthalmic sponge FDA UDI
- Device Name
- This device is used during LASIK surgical procedures to manipulate eye tissue and remove surgical fluid and debris. FDA UDI
- Model / Reference
- 7306 FDA UDI
- Description
- This device is used during LASIK surgical procedures to manipulate eye tissue and remove surgical fluid and debris. FDA UDI
Identifiers
- Catalog Number
- 7306 FDA UDI
- Primary DI / UDI-DI
- 00813465011340 FDA UDI
- 510(k) Number
- K990671 FDA UDI
- FDA Product Code
- HOZ FDA UDI
- GMDN Term
- Ophthalmic sponge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4790 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Ophthalmic sponge
LASIK Spear by Hurricane Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic sponge.
- NETCELL — Network Medical Products, Ltd. · Class II
- Ultracell — Beaver-Visitec International, Inc. · Class II
- NETCELL — Network Medical Products, Ltd. · Class II
- Eyetec — Network Medical Products, Ltd. · Class II
- Visitec® — Beaver-Visitec International, Inc. · Class II
- Coronet — Network Medical Products, Ltd. · Class II
- Kitpack — Network Medical Products, Ltd. · Class II
- Ultracell — Beaver-Visitec International, Inc. · Class II
Cleared under the same submission
K990671 also covers:
- Absorbent Kit — Hurricane Medical
- Absorbent Stick - Non-sterile — Hurricane Medical
- Absorbent Sticks — Hurricane Medical
- Corneal Light Shield — Hurricane Medical
- Corneal Light Shield — Hurricane Medical
- Corneal Light Shield — Hurricane Medical
- Eye Fluid Wick — Hurricane Medical
- Instrument Wipe — Hurricane Medical
- LASIK Drain — Hurricane Medical
- LASIK Drain — Hurricane Medical
- LASIK Shield — Hurricane Medical
- LASIK Sponge — Hurricane Medical
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hurricane Medical
Sources (1)
- FDA UDI 70acd28f-60e2-49c9-a707-e6547975e8ba 36 fields · synced May 30, 2026