Alma Lasers, Inc.
510(k) · clearedClass IIK101147EU
Cleared2007Studies255Trials0
truSculpt flex — FDA clearance record and published evidence
Johari Digital Healthcare Limited · Body Contouring
510(k) · clearedClass IIK212866
PathwayPathwayA 510(k) clearance means FDA agreed the device is substantially equivalent to a device already legally on the market. It is a clearance, not an approval: it is not a finding that the device is effective, and not a comparison against any other product.
Methodology →510(k) · cleared
Methodology →510(k) · cleared
ClassII
First cleared2022
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →4
Methodology →4
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 →—
Methodology →—
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 →—
Methodology →—
A 510(k) device is cleared, not approved — a different route, not a lesser one. What this measuresA 510(k) clearance means FDA agreed the device is substantially equivalent to a device already legally on the market. It is a clearance, not an approval: it is not a finding that the device is effective, and not a comparison against any other product. 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
- —
- Manufacturer
- Johari Digital Healthcare Limited
- Category
- Body Contouring
- Latest decision
- FDA records
- 1
- Mapping
- Verified
Mapping is the weakest link on this page; the rule is published. What this measuresDevice_name 'truSculpt flex', applicant Johari Digital Healthcare Limited (Cutera's manufacturer), product code NGX. MODALITY LEFT NULL ON PURPOSE: this device uses direct bio-electrical muscle stimulation through adhesive electrodes, not the focused electromagnetic field that the existing hifem-muscle-stimulation PubMed query searches for. Assigning it there would attribute HIFEM literature to a non-HIFEM device. 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
| Identifier | Type | Role | FDA record |
|---|---|---|---|
| K212866 | 510(k) — cleared | Primary | Open → |
| Code | FDA device name | 21 CFR |
|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 890.5850 |
Cleared indication: not transcribed here — read it on K212866 → Cleared indicationopenFDA's release of this database does not return the indications-for-use text, and this Index will not paraphrase a regulatory statement it has not transcribed. A 510(k) clearance means FDA agreed the device is substantially equivalent to a device already legally on the market. It is a clearance, not an approval: it is not a finding that the device is effective, and not a comparison against any other product.
Methodology →
Evidence
No modality is assigned to this product, so no literature or trial counts are shown.
Treatment areas
What matched, and where
| Area | Matched term | Source string |
|---|---|---|
| Muscle stimulation | muscle conditioning | FDA product code NGX — Stimulator, Muscle, Powered, For Muscle Conditioning |
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:%22truSculpt%20flex%22&sort=decision_date:desc&limit=100
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=device_name:%22truSculpt%22&sort=decision_date:desc&limit=100
- openFDA classification record for product code NGXhttps://api.fda.gov/device/classification.json?search=product_code:%22NGX%22&limit=1
- FDA public record for K212866https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212866
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 →