What indications did the FDA approve for Neurocept and on what date?

1. A name mix-up: Why Neurocept doesn't appear in core FDA files and what does

The simplest factual anchor is that the FDA materials provided do not consistently list a product named "Neurocept" as an FDA-approved or cleared medical product; instead, FDA 510(k) summaries and clearance letters in the record reference NeuroStar (a TMS therapy system) for Major Depressive Disorder. One analysis explicitly found no mention of Neurocept in an FDA list of accelerated approvals or other FDA pages ^[1]. Another source frames the same device under its commercial name and documents clearances for MDD indications, implying that the original question likely conflates branding or colloquial names with formal regulatory product names ^[2]. This naming ambiguity is important because FDA databases index regulatory actions by manufacturer and product model names, not by every trade or supplement label circulating in the market.

2. The long-standing device clearance: What the 2008 record shows and who it covered

A foundational FDA action in the record is a 510(k) clearance dated November 28, 2008, for a transcranial magnetic stimulation device described in filings as for the treatment of Major Depressive Disorder in adult patients who failed to obtain satisfactory improvement from one prior antidepressant during the current episode. That clearance language establishes the original regulatory foothold for the NeuroStar TMS therapy as a device-based treatment for MDD in adults, which is the clearest, earliest regulatory milestone present in the supplied analyses ^[2]. This 2008 clearance remains relevant because subsequent market claims and later clearances build from that initial device classification rather than from any FDA action tied to a product called Neurocept.

3. Subsequent clearances: Expanding the device's labeled population and claimed benefits

The record contains later 510(k) or clearance entries expanding the device's intended use. One entry documents a clearance on June 14, 2022, for the NeuroStar Advanced Therapy System describing treatment of depressive episodes and decreasing anxiety symptoms in adults with Major Depressive Disorder who had not adequately responded to antidepressants ^[5]. Another entry records a March 22, 2024 clearance (K231926) for adolescent patients ages 15–21 as an adjunctive treatment for MDD, signaling a regulatory expansion to younger populations ^[3]. These later documents show a pattern of device life-cycle approvals and label expansions, which is common for medical devices that enter new indications or populations over time.

4. Conflicting content: Sources asserting Neurocept is not FDA-approved and sold as a supplement

Parallel analyses point to contradictory material asserting that a product called Neurocept is not FDA-approved and is marketed as a dietary supplement or unrelated medicine for cognitive symptoms or dementia; one fact-check style source explicitly states Neurocept is not an FDA-approved treatment for memory loss or cognitive decline ^[4]. Another consumer-facing medication summary lists Neurocept as a product used for mild to moderate Alzheimer's-type dementia but does not provide FDA approval documentation ^[6]. These items suggest two different narratives: one where a legitimate FDA-cleared medical device named NeuroStar exists, and another where commercial products labeled Neurocept operate outside FDA medical approvals as supplements or unapproved therapies.

5. Bottom line and recommended caution when citing approvals

The documentation supports a clear conclusion: there is no consistent FDA approval record under the name "Neurocept" in the supplied sources; the regulatory records instead document approvals and clearances for the NeuroStar TMS device on November 28, 2008, with subsequent clearances in 2022 and 2024 for expanded indications and populations ^{[2] [5] [3]}. Claims that a product called Neurocept received FDA approval are likely the result of branding confusion or conflation between device and supplement names, and consumers and reporters should verify the exact manufacturer and FDA docket/510(k) number before asserting approval status ^[4].