Identity
- Trade Name
- FaceLake FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- The Facelake FL-400 finger pulse oximeter is a lightweight, portable device used for measuring both heart rate and blood oxygen levels or SpO2. FDA UDI
- Model / Reference
- FL-400 FDA UDI
- Description
- The Facelake FL-400 finger pulse oximeter is a lightweight, portable device used for measuring both heart rate and blood oxygen levels or SpO2. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851908007017 FDA UDI
- 510(k) Number
- K082641 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulse oximeter
FaceLake by Lorte Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulse oximeter.
- Nonin — Nonin Medical, Inc. · Class II
- acurio — XIAMEN ACURIO INSTRUMENT CO., LTD · Class II
- MightySat — MASIMO CORPORATION · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
- Andesfit — ANDESFIT LIMITED · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
- ChoiceMMed — Beijing Choice Electronic Technology Co., Ltd. · Class II
Cleared under the same submission
K082641 also covers:
- Care One — Ahold U.S.A., Inc.
- Amazon Basic Care — Amazon.com Services, LLC
- Good Neighbor — Amerisourcebergen Drug Corporation
- Good Neighbor — Amerisourcebergen Drug Corporation
- Pulse oximeter — BETTER BASICS, INC.
- Curaplex — BOUND TREE MEDICAL, LLC
- QUALITY CHOICE — CHAIN DRUG MARKETING ASSOCIATION, INC.
- microdot® — Cambridge Sensors USA, LLC.
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- Virginia National Guard — Clinical Guard
- CONTEC — Contec Medical Systems Co., Ltd.
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
- Lorte Technologies, Inc
Sources (1)
- FDA UDI 7f9512dc-6b8b-4543-a869-75ea30a5a6dc 35 fields · synced Jun 1, 2026