NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'
FDA 510(k) clearance K101967 · decided 2010-08-12
Clearance details
- K-number
- K101967
- Device name
- NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'
- Applicant
- Ellman Int'L, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-13
- Decision date
- 2010-08-12
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Oceanside, NY, 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.