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 |
|---|---|---|---|
| P160042S032 | Revanesse Versa, Revanesse Versa+ (with lidocaine) and Revanesse Lips+ (with lidocaine) | Prollenium Medical Technologies, Inc. | 2026-10-14 |
| P250021S002 | saypha® ChiQ™ | Croma-Pharma GmbH | 2026-10-08 |
| P250021S001 | saypha® ChiQ™ | Croma-Pharma GmbH | 2026-10-07 |
| P140029S058 | Restylane® Contour | Q-Med AB | 2026-09-18 |
| P030050S056 | SCULPTRA® (injectable poly-L Lactic acid) | Q-Med AB | 2026-09-17 |
| P250020S005 | Belotero Volume (+) Lidocaine Dermal Filler | Merz North America, Inc. | 2026-09-10 |
| P250016S004 | Belotero® Intense (+) Lidocaine | Merz North America, Inc. | 2026-08-31 |
| P170002S059 | RHA 2, RHA 3, RHA 4 | Teoxane S.A. | 2026-08-31 |
| P170002S058 | RHA 2, RHA 3, RHA 4 | Teoxane S.A. | 2026-08-28 |
| P110033S102 | Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm | Allergan | 2026-08-28 |
| P050047S107 | Juvéderm Ultra XC, and Juvéderm Ultra Plus XC | Allergan | 2026-08-28 |
| P110033S091 | Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive | Allergan | 2026-08-11 |
| P050047S098 | Ultra, Ultra XC, Ultra Plus XC | Allergan | 2026-08-11 |
| P020012S051 | SANAE® | Tiger Aesthetics Medical, LLC | 2026-08-07 |
| P250016S001 | Belotero® Intense (+) Lidocaine | Merz North America, Inc. | 2026-08-05 |
| P250016S002 | Belotero® Intense (+) Lidocaine | Merz North America, Inc. | 2026-07-31 |
| P170002S055 | RHA® Kiss Volume | Teoxane S.A. | 2026-07-27 |
| P250016 | Belotero® Intense (+) Lidocaine | Merz North America, Inc. | 2026-07-09 |
| P170002S052 | RHA® Redensity, RHA® Redensity Mepi | Teoxane S.A. | 2026-07-02 |
| P050052S179 | RADIESSE® Injectable Implant | Merz North America, Inc. | 2026-06-26 |
| P050037S154 | RADIESSE® Injectable Implant | Merz North America, Inc. | 2026-06-26 |
| P250020S002 | Belotero Volume (+) Lidocaine Dermal Filler | Merz North America, Inc. | 2026-06-25 |
| P250020S003 | Belotero Volume (+) Lidocaine | Merz North America, Inc. | 2026-06-23 |
| P030050S055 | SCULPTRA® (injectable poly-L Lactic acid) | Q-Med AB | 2026-06-22 |
| P250020S001 | Belotero Volume (+) Lidocaine | Merz North America, Inc. | 2026-06-17 |
| P250021 | saypha® ChiQ™ | Croma-Pharma GmbH | 2026-06-12 |
| P110033S099 | SKINVIVE by JUVEDERM® | Allergan | 2026-06-11 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08057607270048 | Juvederm Volux | NUVARA SRL | 2026-10-15 |
| 08057607270055 | Juvederm Voluma | NUVARA SRL | 2026-10-15 |
| 08057607270086 | Radiesse | NUVARA SRL | 2026-10-15 |
| 08057607270093 | Restylane Lido | NUVARA SRL | 2026-10-15 |
| 08057607270109 | Restylane Lyft | NUVARA SRL | 2026-10-15 |
| 08057607270116 | Restylane Refyne | NUVARA SRL | 2026-10-15 |
| 08057607270123 | Restylane Kysse | NUVARA SRL | 2026-10-15 |
| 08057607270130 | Restylane Defyne | NUVARA SRL | 2026-10-15 |
| 08057607270147 | Sculptra | NUVARA SRL | 2026-10-15 |
| 08057607270031 | Juvederm Volbella | NUVARA SRL | 2026-10-15 |
| 07640123792999 | Belotero Volume (+) Lidocaine | ANTEIS SA | 2026-08-08 |
| 07640123792982 | Belotero Volume (+) Lidocaine | ANTEIS SA | 2026-08-08 |
| 04262487270222 | Radiesse (+) Lidocaine | Pharmamondis GmbH | 2026-06-24 |
| 07640123793316 | Belotero Balance Lidocaine | ANTEIS SA | 2025-09-30 |
| 07640123793309 | Belotero Balance Lidocaine | ANTEIS SA | 2025-09-30 |
| 07640173233527 | RHA® 2 Mepi | Teoxane SA | 2024-10-18 |
| 07640173233497 | RHA® Redensity™ Mepi | Teoxane SA | 2024-10-18 |
| 07640173233480 | RHA® 4 Mepi | Teoxane SA | 2024-10-18 |
| 07640173233473 | RHA® 3 Mepi | Teoxane SA | 2024-10-18 |
| 07640123791343 | Belotero Balance (+) Lidocaine | ANTEIS SA | 2023-06-01 |
| 07640123791152 | Belotero Balance | ANTEIS SA | 2023-06-01 |
| 07640123791145 | Belotero Balance (+) Lidocaine | ANTEIS SA | 2023-06-01 |
| 07640173231653 | RHA® Redensity | Teoxane SA | 2022-05-03 |
| 07640173232704 | RHA® 4 | Teoxane SA | 2022-03-23 |
| 07640123791138 | Belotero Balance (+) Lidocaine | ANTEIS SA | 2021-01-01 |
| 07640123791220 | Belotero Balance (+) Lidocaine | ANTEIS SA | 2021-01-01 |
| 07640123791213 | Belotero Balance | ANTEIS SA | 2020-10-01 |
| 07640173230045 | RHA® 3 | Teoxane SA | 2020-05-30 |
| 10888628044746 | JUVEDERM ULTRA | Allergan, Inc. | 2019-04-22 |
| 07640123791121 | Belotero Balance | ANTEIS SA | 2019-02-01 |