Belotero Intense (+) Lidocaine Dermal Filler
Merz North America, Inc. · Implant, dermal, for aesthetic use · General, Plastic Surgery
Open FDA's page for this record- PMA number
- P250016
- Supplement number
- S006
- Applicant
- Merz North America, Inc.
- Street 1
- 6501 Six Forks Rd.
- City
- Raleigh
- State
- NC
- Zip
- 27615
- Generic name
- Implant, dermal, for aesthetic use
- Trade name
- Belotero Intense (+) Lidocaine Dermal Filler
- Product code
- LMH
- Advisory committee
- SU
- Advisory committee description
- General, Plastic Surgery
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-09-23
- Decision date
- 2026-10-21
- Decision code
- OK30
- Ao statement
- Approval for modifications to the manual cleaning process for utensils and equipment used in the manufacture of Belotero Intense (+) Lidocaine dermal fillers.
- Harmonized identifiers (openFDA)
- Device name
- Implant, Dermal, For Aesthetic Use
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3007744205, 3003672980, 3048051492, 3022121566, 3043624366, 9710154, 3004423487, 3003707320, 3037006441, 3002806738, 3033486016, 3004362706, 3019585045, 3006123332, 3010164402, 3026391021, 3031056804, 3031983053, 1000118068, 3005113652, 3015373820, 3043045982, 3007772056, 3006999111, 3013840437, 3002807108, 2135225, 3005975625, 3036164410, 3042708459, 3009882464, 3045078914, 3015471896, 2011068, 3027345797
- FEI number
- 3007744205, 3003672980, 3048051492, 3022121566, 3007517952, 3043624366, 3004423487, 3003707320, 3037006441, 3002806738, 3033486016, 3004362706, 3019585045, 3006123332, 3026391021, 3031056804, 3031983053, 1000118068, 3005113652, 3015373820, 3043045982, 3007772056, 3006999111, 3013840437, 3002807108, 3005975625, 3003347293, 3036164410, 3042708459, 3009882464, 3045078914, 3015471896, 3003407669, 2011068, 3027345797