Identity
- Trade Name
- Cluster Applicator 5402 FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, professional FDA UDI
- Device Name
- 660/950 nm SLD/LED cluster applicator FDA UDI
- Model / Reference
- 5402 FDA UDI
- Description
- 660/950 nm SLD/LED cluster applicator FDA UDI
Identifiers
- Catalog Number
- 5402 FDA UDI
- Primary DI / UDI-DI
- 00816864020555 FDA UDI
- 510(k) Number
- K043586 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal/physical therapy laser, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 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
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
Yes
FDA UDI
Category: Musculoskeletal/physical therapy laser, professional
Cluster Applicator 5402 by Mettler Electronics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Musculoskeletal/physical therapy laser, professional.
- Dimed — Wuhan Dimed Laser Technology Co., Ltd. · Class II
- LZ30 — AVANT WELLNESS SYSTEMS INC · Class II
- iLux LF D20 — MECTRONIC MEDICALE SRL · Class II
- EVRL — Erchonia Corporation · Class II
- Regenalase — IPG Medical Corporation · Class II
- Phoenix Thera-Lase system — Phoenix Thera-Lase Systems, LLC · Class II
- Diode Laser System Deep Tissue Handpiece — Biolase, Inc. · Class II
- MedX Rehab Portable Laser — MedX Health Corp · Class II
Cleared under the same submission
K043586 also covers:
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
- Mettler Electronics Corp.
Sources (1)
- FDA UDI 719ea96a-3c47-4973-a49e-cc869de937cf 37 fields · synced May 30, 2026