RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
FDA 510(k) clearance K033183 · decided 2004-04-15
Clearance details
- K-number
- K033183
- Device name
- RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
- Applicant
- Curelight, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-01
- Decision date
- 2004-04-15
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.