Identity
- Trade Name
- Loox FDA UDI
- Generic Name
- Soft corrective contact lens, daily-wear FDA UDI
- Device Name
- 3 Tone Hazel Contact Lenses FDA UDI
- Model / Reference
- 09.506 FDA UDI
- Description
- 3 Tone Hazel Contact Lenses FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00696792095067 FDA UDI
- 510(k) Number
- K123431 FDA UDI
- FDA Product Code
- LPL FDA UDI
- GMDN Term
- Soft corrective contact lens, daily-wear 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
No
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
No
FDA UDI
Category: Soft corrective contact lens, daily-wear
Loox by Camden Passage 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-wear.
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- PolyVue — INTEROJO INC. · Class II
- HAPA KRISTIN — INTEROJO INC. · Class II
- ArtMost SoftOK Daily Wear Soft Contact Lens — SEINOH OPTICAL CO., LTD. · Class II
- ArtMost SoftOK Daily Wear Soft Contact Lens — SEINOH OPTICAL CO., LTD. · Class II
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Cleared under the same submission
K123431 also covers:
- Loox — Camden Passage Inc
- Loox — Camden Passage Inc
- Loox — Camden Passage Inc
- Loox — Camden Passage Inc
- Loox — Camden Passage Inc
- Loox — Camden Passage Inc
- Loox — Camden Passage Inc
- Loox — Camden Passage Inc
- Loox — Camden Passage Inc
- Loox — Camden Passage Inc
- Loox — Camden Passage Inc
- Loox — Camden Passage 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Camden Passage Inc
Sources (1)
- FDA UDI ed905e17-fe80-4061-8a6f-a899adee174f 34 fields · synced Jun 1, 2026