Product code LMH
- Device name
- Implant, Dermal, For Aesthetic Use
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P250020 | Belotero Volume (+) Lidocaine | Merz North America, Inc. | 2026-05-19 |
| P140029S057 | Restylane® Contour | Q-Med AB | 2026-05-15 |
| P050052S178 | RADIESSE® Injectable Implant, RADIESSE® Hands | Merz North America, Inc. | 2026-05-14 |
| P050037S153 | RADIESSE® Injectable Implant | Merz North America, Inc. | 2026-05-14 |
| P170002S050 | RHA Redensity® Eye Lido; RHA Redensity® Eye | Teoxane S.A. | 2026-05-12 |
| P020012S052 | Bellafill® Dermal Filler | Tiger Aesthetics Medical, LLC | 2026-05-12 |
| P160042S031 | Revanesse Versa / Revanesse Versa+ (with lidocaine) / Revanesse Lips+ (with lidocaine) | Prollenium Medical Technologies, Inc. | 2026-05-08 |
| P090016S067 | Belotero Balance Dermal Filler; Belotero Balance (+) Lidocaine | Merz North America, Inc. | 2026-05-03 |
| P030050S054 | SCULPTRA AND SCULPTRA AESTHETIC | Q-Med AB | 2026-04-15 |
| P140029S056 | Restylane® Refyne, Restylane® Defyne, Restylane® Kysse and Restylane® Contour | Q-Med AB | 2026-04-14 |
| P170002S041 | RHA 2, RHA 3, RHA 4 | Teoxane S.A. | 2026-04-07 |
| P170002S054 | RHA® Redensity, RHA® Redensity™ Mepi, RHA®2 and RHA®2 Mepi, RHA®3 and RHA®3 Mepi, RHA®4 and RHA® Dynamic Volume | Teoxane S.A. | 2026-04-01 |
| P170002S053 | RHA® Redensity™ Mepi (also called RHA®1 Mepi), RHA®2 Mepi, RHA®3 Mepi, RHA® Dynamic Volume (formerly called RHA®4 Mepi) | Teoxane S.A. | 2026-03-31 |
| P050052S162 | RADIESSE® Injectable Implant | Merz North America, Inc. | 2026-03-31 |
| P050052S177 | P050052 RADIESSE® Injectable Implant; RADIESSE® Hands; RADIESSE® (+) Lidocaine; Jawline indication | Merz North America, Inc. | 2026-03-24 |
| P050052S176 | RADIESSE® Injectable Implant | Merz North America, Inc. | 2026-03-24 |
| P050037S152 | RADIESSE® Injectable Implant | Merz North America, Inc. | 2026-03-24 |
| P050037S151 | RADIESSE® Injectable Implant | Merz North America, Inc. | 2026-03-24 |
| P140029S054 | Restylane® Contour | Q-Med AB | 2026-03-20 |
| P050052S175 | RADIESSE® Injectable Implant | Merz North America, Inc. | 2026-03-18 |
| P050037S150 | RADIESSE® Injectable Implant | Merz North America, Inc. | 2026-03-18 |
| P040024S148 | RESTYLANE INJECTABLE GEL | Q-Med AB | 2026-03-12 |
| P240022S005 | Evolysse™ Smooth; Evolysse™ Form | Symatese | 2026-02-27 |
| P040024S147 | Restylane Lyft with Lidocaine | Q-Med AB | 2026-02-05 |
| P040024S143 | Restylane®-L 1 mL; Restylane® Lyft™ with Lidocaine 1 mL; Restylane® Eyelight™ 0.5 mL | Q-Med AB | 2026-01-29 |
| P170002S051 | RHA® Redensity dermal filler | Teoxane S.A. | 2026-01-14 |
| P050052S174 | RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication | Merz North America, Inc. | 2026-01-13 |
| P050037S149 | RADIESSE® Injectable Implant | Merz North America, Inc. | 2026-01-13 |
| P040024S146 | Restylane® Lyft with Lidocaine | Q-Med AB | 2025-12-23 |
| P160042S029 | Revanesse Versa; Revanesse Versa+ (with lidocaine); Revanesse Lips+ (with lidocaine) | Prollenium Medical Technologies, Inc. | 2025-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08437027710117 | SCULPTRA | SAIMA GLOBAL FARMA S.L. | 2026-02-19 |
| 07640173236283 | RHA® Dynamic Volume | Teoxane SA | 2025-12-18 |
| 07640173236177 | RHA® 3 Mepi | Teoxane SA | 2025-05-01 |
| 07640173233473 | RHA® 3 Mepi | Teoxane SA | 2024-10-18 |
| 07640173233480 | RHA® 4 Mepi | Teoxane SA | 2024-10-18 |
| 07640173233497 | RHA® Redensity™ Mepi | Teoxane SA | 2024-10-18 |
| 07640173233527 | RHA® 2 Mepi | Teoxane SA | 2024-10-18 |
| 10840228302831 | JUVEDERM VOLUX XC 1ML SAMPLE | Allergan, Inc. | 2024-04-10 |
| 10840228302763 | SKINVIVE BY JUVEDERM XC 1ML SAMPLE | Allergan, Inc. | 2024-04-10 |
| 10840228302770 | JUVEDERM ULTRA PLUS XC 1ML SAMPLE | Allergan, Inc. | 2024-04-10 |
| 10840228302787 | JUVEDERM ULTRA XC 1ML SAMPLE | Allergan, Inc. | 2024-04-10 |
| 10840228302794 | JUVEDERM VOLBELLA XC 1ML SAMPLE | Allergan, Inc. | 2024-04-10 |
| 10840228302800 | JUVEDERM VOLBELLA XC 0.55ML SAMPLE | Allergan, Inc. | 2024-04-10 |
| 10840228302817 | JUVEDERM VOLLURE XC 1ML SAMPLE | Allergan, Inc. | 2024-04-10 |
| 10840228302824 | JUVEDERM VOLUMA XC 1ML SAMPLE | Allergan, Inc. | 2024-04-10 |
| 07640173234128 | RHA® 2 | Teoxane SA | 2024-03-22 |
| 07640173234173 | RHA® 3 | Teoxane SA | 2024-03-18 |
| 10840228300066 | Skinvive | Allergan, Inc. | 2023-05-22 |
| 07640173231653 | RHA® Redensity | Teoxane SA | 2022-05-03 |
| 07640173232704 | RHA® 4 | Teoxane SA | 2022-03-23 |
| 07640173230045 | RHA® 3 | Teoxane SA | 2020-05-30 |
| M2138071M0K25 | Radiesse Volume Advantage | MERZ NORTH AMERICA, INC. | 2016-09-09 |
| M2138063M0K25 | Radiesse (+) Lidocaine | MERZ NORTH AMERICA, INC. | 2016-09-09 |
| M2138071M0H15 | Radiesse Injectable Implant1.5cc | MERZ NORTH AMERICA, INC. | 2016-06-24 |
| M2138071C0K15 | Radiesse Volume Advantage 1.5cc | MERZ NORTH AMERICA, INC. | 2016-03-30 |
| M2138067M0K15 | Radiesse (+) Lidocaine 0.8cc Injectable Implant | MERZ NORTH AMERICA, INC. | 2015-08-19 |
| M2138063M0K15 | Radiesse (+) Lidocaine1.5cc Injectable Implant | MERZ NORTH AMERICA, INC. | 2015-08-19 |
| 10888628000018 | JUVEDERM VOLUMA XC | Allergan, Inc. | 2014-09-17 |
| M2138071M0K15 | Radiesse Volume Advantage 1.5cc | MERZ NORTH AMERICA, INC. | 2014-09-17 |
| M2138069M0K15 | Radiesse Moderate Fill 0.8cc | MERZ NORTH AMERICA, INC. | 2014-09-17 |