PMA P020012

Device
Bellafill® Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S041
Product code
LMH
Decision date
2026-05-12
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