FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)
K Number: K253965
·
Decision Mar 19, 2026
Classifications
1
FEI Numbers
462
Registration Numbers
462
Same Product Code
228
Applicant Total
1
Review Days
98
Basic Information
- Device Name
- CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)
- K Number
- K253965
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wuhan PHOMED Technology Company , Ltd.
- Date Received
- December 11, 2025
- Decision Date
- March 19, 2026
- Product Code
- ILY
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- SU
- 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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