Zimmer Medizinsysteme GmbH · Body Contouring
510(k) · clearedClass IIK253408
Cleared2019Studies61Trials4
Devices linked to muscle stimulation
5 products · matched by keyword rule, not the cleared indication
5 products
Maker — · Body Contouring
Unverified mapping
Decision—Studies61Trials4
Bios S.R.L. · Body Contouring
510(k) · clearedClass IIK230755EU
Cleared2020Studies255Trials0
Sofwave Medical, Ltd. · Body Contouring
510(k) · clearedClass IIK250146EU
Cleared2021Studies317Trials16
Johari Digital Healthcare Limited · Body Contouring
510(k) · clearedClass IIK212866
Cleared2022Studies—Trials—
| Product | Manufacturer | Category | Pathway | Class | First decision | Studies | Trials |
|---|---|---|---|---|---|---|---|
| CoolTone | Zimmer Medizinsysteme GmbH | Body Contouring | 510(k) — cleared | Class II | Nov 15 2019 | 61 | 4 |
| Emsculpt NEO | — | Body Contouring | Not verified | — | — | 61 | 4 |
| NuEra Tight EU | Bios S.R.L. | Body Contouring | 510(k) — cleared | Class II | Aug 11 2020 | 255 | 0 |
| Sofwave EU | Sofwave Medical, Ltd. | Body Contouring | 510(k) — cleared | Class II | Nov 15 2021 | 317 | 16 |
| truSculpt flex | Johari Digital Healthcare Limited | Body Contouring | 510(k) — cleared | Class II | Dec 3 2022 | — | — |
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Curated seed list; study and trial counts are per modality, not per brand. What this measuresThis is a curated seed list of widely used medical-aesthetic products, each crosswalked to a real FDA record where one could be found with confidence. Being listed is not an endorsement, not a ranking and not a claim of market share. Being absent is not a judgement — it means the product is not in this seed list yet. Counts beside each filter are live counts of the products currently matching your other filters. Manufacturer is the applicant or sponsor field of the FDA record, printed exactly as FDA publishes it, so one company can appear under more than one string.
Methodology →
Sorted by most recent FDA decision — a filing date, not a quality signal. What each ordering measuresEvery ordering on this page is a proxy built from public records, never a quality judgement. Orders products by the most recent FDA decision date matched to the brand name, including later submissions and supplements. A recent date means the manufacturer filed again; it does not mean the product is newer, improved, more popular or better. Orders products by the number of PubMed records matching a fixed query for the product's MODALITY, never its brand name. It counts how much has been published about a technique. It is not a quality score, not an efficacy measure, not a count of randomised trials, and not comparable between techniques of different ages. Orders products by the number of ClinicalTrials.gov studies matching a fixed intervention-plus-condition query for the product's MODALITY, never its brand. Registration is not completion, not publication and not a result. Alphabetical by product name. No ranking, quality judgement or ordering of merit is implied by the position of anything in this list. Orders products by the earliest FDA decision date matched to the brand name. For drugs approved under a BLA or NDA the original approval can long predate any cosmetic indication, so an early date is not a cosmetic-use date.
Methodology →
How each product matched (5)
| Product | Matched term | Source string |
|---|---|---|
| CoolTone | muscle strengthening | ClinicalTrials.gov condition query for High-intensity electromagnetic muscle stimulation |
| Emsculpt NEO | muscle strengthening | ClinicalTrials.gov condition query for High-intensity electromagnetic muscle stimulation |
| NuEra Tight | muscle conditioning | FDA product code NGX — Stimulator, Muscle, Powered, For Muscle Conditioning |
| Sofwave | muscle conditioning | FDA product code NGX — Stimulator, Muscle, Powered, For Muscle Conditioning |
| truSculpt flex | muscle conditioning | FDA product code NGX — Stimulator, Muscle, Powered, For Muscle Conditioning |
Derived by keyword rule from real source strings, not the cleared indication. What this measuresTreatment areas are DERIVED, not copied from an FDA field. A fixed keyword list is run over two real strings: the ClinicalTrials.gov condition query actually executed for this product's modality on the run date, and the device names of the FDA product codes attached to this product's records. The words "skin" and "cosmetic" are ignored because every query contains one of them. An area is not the cleared or approved indication — openFDA's 510(k) response does not carry the indications-for-use text, and this Index does not paraphrase it. Products whose source query or FDA product code names muscle stimulation, conditioning or strengthening.
Methodology →