Identity
- Trade Name
- IDEAL SiHy/1Day/30PK FDA UDI
- Generic Name
- Soft corrective contact lens, daily-disposable FDA UDI
- Device Name
- Sihy/UV/60T/PWR: -6.50 FDA UDI
- Model / Reference
- 9M40 FDA UDI
- Description
- Sihy/UV/60T/PWR: -6.50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840486900247 FDA UDI
- 510(k) Number
- K242413 FDA UDI
- FDA Product Code
- MVN FDA UDILPL FDA UDI
- GMDN Term
- Soft corrective contact lens, daily-disposable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5925 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Soft corrective contact lens, daily-disposable
IDEAL SiHy/1Day/30PK by Vizionfocus Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Soft corrective contact lens, daily-disposable.
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Cleared under the same submission
K242413 also covers:
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS INC.
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS INC.
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS INC.
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS INC.
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS INC.
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS INC.
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS INC.
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS INC.
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS INC.
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS INC.
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS INC.
- IDEAL SiHy/1Day/30PK — VIZIONFOCUS 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 II | Pending data |
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Manufacturer
- Manufacturer
- Vizionfocus Inc.
Sources (1)
- FDA UDI d661b63d-a755-46ce-ac12-e9ae7df56f33 34 fields · synced Jun 6, 2026