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: -8.00 FDA UDISihy/UV/60T/PWR: -7.00 FDA UDISihy/UV/60T/PWR: -5.00 FDA UDISihy/UV/60T/PWR: -1.25 FDA UDISihy/UV/60T/PWR: +3.00 FDA UDISihy/UV/60T/PWR: +4.75 FDA UDISihy/UV/60T/PWR: -9.50 FDA UDISihy/UV/60T/PWR: -4.50 FDA UDISihy/UV/60T/PWR: -10.50 FDA UDI
- Model / Reference
- 9M40 FDA UDI
- Description
- Sihy/UV/60T/PWR: -8.00 FDA UDISihy/UV/60T/PWR: -7.00 FDA UDISihy/UV/60T/PWR: -5.00 FDA UDISihy/UV/60T/PWR: -1.25 FDA UDISihy/UV/60T/PWR: +3.00 FDA UDISihy/UV/60T/PWR: +4.75 FDA UDISihy/UV/60T/PWR: -9.50 FDA UDISihy/UV/60T/PWR: -4.50 FDA UDISihy/UV/60T/PWR: -10.50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840486900278 FDA UDI00840486900254 FDA UDI00840486900193 FDA UDI00840486900049 FDA UDI00840486900476 FDA UDI00840486900544 FDA UDI00840486900308 FDA UDI00840486900179 FDA UDI00840486900322 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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- Miru 1day Menicon Flat Pack TC CP90 — MENICON CO., LTD. · Class II
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 (9)
- FDA UDI 2f7246dd-e5ab-480b-8512-acb33e574c29 34 fields · synced Jun 8, 2026
- FDA UDI e52c4166-dc3b-4605-bb2d-58c10b4c488f 34 fields · synced May 24, 2026
- FDA UDI dc64ff6e-8c4f-4427-b2e5-b250b1934081 34 fields · synced May 24, 2026
- FDA UDI 8dc4d5e9-564f-49fe-9b52-1fcb62375bfa 34 fields · synced May 24, 2026
- FDA UDI 70b1373c-357e-4751-961f-31b272f3edf9 34 fields · synced May 25, 2026
- FDA UDI 18aeb646-8bab-44c2-97ec-cd490aff531c 34 fields · synced May 25, 2026
- FDA UDI d3e4d976-bc5c-4a18-93de-379d8e50de7f 34 fields · synced May 25, 2026
- FDA UDI 79913e93-de9b-4489-a39f-1fbf16f5baec 34 fields · synced May 25, 2026
- FDA UDI 76e714a1-a98f-440b-9457-f470058931b1 34 fields · synced May 26, 2026