Alma Lasers, Inc.
510(k) · clearedClass IIK101147EU
Cleared2007Studies255Trials0
Emsculpt NEO — no FDA record matched to this brand name
Maker — · Body Contouring · High-intensity electromagnetic muscle stimulation
Unverified mapping
PathwayPathwayNo FDA record could be matched to this brand name with confidence, so this page claims no pathway, no clearance or approval number and no date. Nothing here is guessed to fill the gap.
Methodology →—
Methodology →—
ClassClassNo FDA record was matched to this brand, so no product code and no device class could be read.
Methodology →—
Methodology →—
First decision—
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →—
Methodology →—
StudiesStudiesPubMed records for a fixed query about the MODALITY, not the brand. It measures 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 modalities of different ages. It says nothing about this brand specifically.
Methodology →61
Methodology →61
TrialsTrialsClinicalTrials.gov studies for a fixed query about the MODALITY, not the brand. Registration is not completion, not publication and not a result. Counts include studies of any status, size or sponsor, and the recruiting figure is a snapshot taken on the run date. Device studies are under-registered relative to drug studies.
Methodology →4
Methodology →4
No FDA record matched this brand, so nothing regulatory is claimed here. What this measuresNo FDA record could be matched to this brand name with confidence, so this page claims no pathway, no clearance or approval number and no date. Nothing here is guessed to fill the gap. It measures 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 modalities of different ages. It says nothing about this brand specifically.
Methodology →
Shares treatment areas — not a recommendation. What this measuresPicked mechanically, by rule and nothing else: products in the same Index category that share the most derived treatment areas with this one, ties broken alphabetically. Treatment areas are themselves derived by a published keyword rule run over a real source string, not copied from the cleared or approved indication, so a shared area means two products' source strings happened to use the same word. It does not mean the two products do the same job, it is not a claim that they are interchangeable, and it is not a recommendation.
Methodology →
Overview
- Modality
- High-intensity electromagnetic muscle stimulation
- Manufacturer
- —
- Category
- Body Contouring
- Latest decision
- —
- FDA records
- —
- Mapping
- Not verified
Mapping is the weakest link on this page; the rule is published. What this measuresNo openFDA 510(k) record carries this brand name in its device_name field. Many platforms are cleared under an internal system or model name rather than the marketing name, so a K-number cannot be assigned without guessing. Left null on purpose. A mapping is the weakest link on this page: if it is wrong, every number above it is about the wrong product. It is stated in full so it can be checked.
Methodology →
Regulatory
Unverified mapping
No clearance number, approval number, device class, manufacturer or date is shown for this product. Nothing is guessed to fill the gap.
Indication: none shown, because no FDA record was matched to this brand name. IndicationNo FDA record could be matched to this brand name with confidence, so this page claims no pathway, no clearance or approval number and no date. Nothing here is guessed to fill the gap.
Methodology →
Evidence
Counted for the modality, never the brand.
61PubMed, all time
61PubMed, 10y
4Studies
0Recruiting
| High-intensity electromagnetic muscle stimulation | |
|---|---|
| 2016 | 0 |
| 2017 | 0 |
| 2018 | 4 |
| 2019 | 6 |
| 2020 | 8 |
| 2021 | 14 |
| 2022 | 9 |
| 2023 | 14 |
| 2024 | 8 |
| 2025 | 5 |
| 2026 | 4 |
5papers · 2025 · modality, not brand−38%
PubMed counts publications; ClinicalTrials.gov counts registrations. Neither is a quality score. What this measuresPubMed record counts and ClinicalTrials.gov study counts for a fixed query about the MODALITY, never the brand. It measures 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 modalities of different ages. It says nothing about this brand specifically. Registration is not completion, not publication and not a result. Counts include studies of any status, size or sponsor, and the recruiting figure is a snapshot taken on the run date. Device studies are under-registered relative to drug studies. The same counts apply to every other product in the Index on this modality: CoolTone. The trend line is the same fixed modality query windowed per publication year. Number of PubMed records matching each modality's fixed, hand-written title/abstract query, windowed to a single publication year. It measures publication volume about a TECHNIQUE, not a brand. It is NOT a quality score, NOT an efficacy measure, and NOT a count of randomised trials. 2026 is a partial year (run date 2026-07-26); its bar is short because the year is short, not because interest fell. 2026 contains only papers indexed by the run date (2026-07-26). Render it visually distinct (e.g. hollow/hatched) or annotate it; never let it read as a decline.
Methodology →
PubMed query, verbatim
("high-intensity focused electromagnetic"[tiab] OR "HIFEM"[tiab] OR "high intensity focused electromagnetic"[tiab] OR ("electromagnetic"[tiab] AND "muscle stimulation"[tiab] AND "body contouring"[tiab])) AND (muscle*[tiab] OR abdomen[tiab] OR buttock*[tiab] OR "body contouring"[tiab] OR fat[tiab])
ClinicalTrials.gov query, verbatim
intervention: ("HIFEM" OR "high intensity focused electromagnetic" OR "electromagnetic muscle stimulation") condition: ("body contouring" OR "muscle strengthening" OR "abdominal fat" OR cosmetic OR "body composition")
Treatment areas
What matched, and where
| Area | Matched term | Source string |
|---|---|---|
| Fat & body contouring | body contouring | ClinicalTrials.gov condition query for High-intensity electromagnetic muscle stimulation |
| Muscle stimulation | muscle strengthening | ClinicalTrials.gov condition query for High-intensity electromagnetic muscle stimulation |
Derived by keyword rule, not the cleared or approved 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.
Methodology →
Sources
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=device_name:%22Emsculpt%20NEO%22&sort=decision_date:desc&limit=100
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=device_name:%22Emsculpt%22&sort=decision_date:desc&limit=100
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=applicant:%22BTL%22&sort=decision_date:desc&limit=100
- PubMed count, all timehttps://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&rettype=count&term=%28%22high-intensity%20focused%20electromagnetic%22%5Btiab%5D%20OR%20%22HIFEM%22%5Btiab%5D%20OR%20%22high%20intensity%20focused%20electromagnetic%22%5Btiab%5D%20OR%20%28%22electromagnetic%22%5Btiab%5D%20AND%20%22muscle%20stimulation%22%5Btiab%5D%20AND%20%22body%20contouring%22%5Btiab%5D%29%29%20AND%20%28muscle%2A%5Btiab%5D%20OR%20abdomen%5Btiab%5D%20OR%20buttock%2A%5Btiab%5D%20OR%20%22body%20contouring%22%5Btiab%5D%20OR%20fat%5Btiab%5D%29
- PubMed count, last 10 yearshttps://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&rettype=count&term=%28%22high-intensity%20focused%20electromagnetic%22%5Btiab%5D%20OR%20%22HIFEM%22%5Btiab%5D%20OR%20%22high%20intensity%20focused%20electromagnetic%22%5Btiab%5D%20OR%20%28%22electromagnetic%22%5Btiab%5D%20AND%20%22muscle%20stimulation%22%5Btiab%5D%20AND%20%22body%20contouring%22%5Btiab%5D%29%29%20AND%20%28muscle%2A%5Btiab%5D%20OR%20abdomen%5Btiab%5D%20OR%20buttock%2A%5Btiab%5D%20OR%20%22body%20contouring%22%5Btiab%5D%20OR%20fat%5Btiab%5D%29%20AND%20%28%222016%2F01%2F01%22%5Bdp%5D%20%3A%20%222026%2F12%2F31%22%5Bdp%5D%29
- ClinicalTrials.gov, all studieshttps://clinicaltrials.gov/api/v2/studies?query.intr=%28%22HIFEM%22%20OR%20%22high%20intensity%20focused%20electromagnetic%22%20OR%20%22electromagnetic%20muscle%20stimulation%22%29&query.cond=%28%22body%20contouring%22%20OR%20%22muscle%20strengthening%22%20OR%20%22abdominal%20fat%22%20OR%20cosmetic%20OR%20%22body%20composition%22%29&countTotal=true&pageSize=1&fields=NCTId
- ClinicalTrials.gov, recruiting onlyhttps://clinicaltrials.gov/api/v2/studies?query.intr=%28%22HIFEM%22%20OR%20%22high%20intensity%20focused%20electromagnetic%22%20OR%20%22electromagnetic%20muscle%20stimulation%22%29&query.cond=%28%22body%20contouring%22%20OR%20%22muscle%20strengthening%22%20OR%20%22abdominal%20fat%22%20OR%20cosmetic%20OR%20%22body%20composition%22%29&filter.overallStatus=RECRUITING&countTotal=true&pageSize=1&fields=NCTId
No adverse-event data is published anywhere on this site. What this measuresNo adverse-event data appears anywhere on this site. MAUDE and FAERS were never queried: those counts have no denominator, reporting is voluntary and duplicated, and a report is not evidence of causation. Publishing them beside a brand name would mislead.
Methodology →