Identity
- Trade Name
- MIRA Minor Surgery Light FDA UDI
- Generic Name
- Fixed examination/treatment room light FDA UDI
- Device Name
- Mira LED 65, Ceiling Mount, Double, Extended Arm FDA UDI
- Model / Reference
- MIRA FDA UDI
- Description
- Mira LED 65, Ceiling Mount, Double, Extended Arm FDA UDI
Identifiers
- Catalog Number
- L-MLED65-CM-DC-EX FDA UDI
- Primary DI / UDI-DI
- 00667774000096 FDA UDI
- 510(k) Number
- K131893 FDA UDI
- FDA Product Code
- FSY FDA UDI
- GMDN Term
- Fixed examination/treatment room light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fixed examination/treatment room light
MIRA Minor Surgery Light by Amico Lights Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131893 also covers:
- MIRA Minor Surgery Light — Amico Lights Corporation
- MIRA Minor Surgery Light — Amico Lights Corporation
- MIRA Minor Surgery Light — Amico Lights Corporation
- MIRA Minor Surgery Light — Amico Lights Corporation
- MIRA Minor Surgery Light — Amico Lights Corporation
- MIRA Minor Surgery Light — Amico Lights Corporation
- MIRA Minor Surgery Light — Amico Lights Corporation
- MIRA Minor Surgery Light — Amico Lights Corporation
- MIRA Minor Surgery Light — Amico Lights Corporation
- MIRA Minor Surgery Light — Amico Lights Corporation
- MIRA Minor Surgery Light — Amico Lights Corporation
- MIRA Minor Surgery Light — Amico Lights Corporation
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
- Amico Lights Corporation
Sources (1)
- FDA UDI 17e10ae6-45c8-43db-a921-1bf92bf7b54a 37 fields · synced May 30, 2026