FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUCIA
K Number: K102375
·
Decision Feb 25, 2011
Classifications
1
FEI Numbers
462
Registration Numbers
462
Same Product Code
228
Applicant Total
7
Review Days
189
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Basic Information
- Device Name
- LUCIA
- K Number
- K102375
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meridian Co., Ltd.
- Date Received
- August 20, 2010
- Decision Date
- February 25, 2011
- Product Code
- ILY
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | FDA class 2 | Physical Medicine |
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Other Clearances by Meridian Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K081962 | LAPEX BCS | Dec 29, 2008 | Substantially Equivalent |
| K034009 | LAPEX 2000 | Jan 21, 2005 | Substantially Equivalent |
| K023238 | MCPULSE | Feb 19, 2003 | Substantially Equivalent |
| K020360 | ABR-2000 | Aug 29, 2002 | Substantially Equivalent |
| K010897 | MERIDIAN-PORTABLE | Jun 19, 2001 | Substantially Equivalent |
| K001347 | MERIDIAN-II AND MERDIAN-PLUS | Nov 3, 2000 | Substantially Equivalent |