PMA P020012S052
- Device
- Bellafill® Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S052
- Product code
- LMH
- Decision date
- 2026-05-12
- Classification
- General, Plastic Surgery
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- Approval for changes to bulk mixing equipment during subassembly manufacturing of the Bellafill Dermal Filler device and Bellafill Skin Test accessory
Current openFDA PMA Record#
- Device
- Bellafill® Dermal Filler
- Applicant
- Tiger Aesthetics Medical, LLC
- PMA number
- P020012
- Supplement
- S052
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2026-05-12
- Decision code
- OK30
- Date received
- 2026-04-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes to bulk mixing equipment during subassembly manufacturing of the Bellafill Dermal Filler device and Bellafill Skin Test accessory