<?xml version="1.0"?>
<ownershipDocument>

    <schemaVersion>X0609</schemaVersion>

    <documentType>4</documentType>

    <periodOfReport>2026-09-30</periodOfReport>

    <notSubjectToSection16>0</notSubjectToSection16>

    <issuer>
        <issuerCik>0001688757</issuerCik>
        <issuerName>ESTABLISHMENT LABS HOLDINGS INC.</issuerName>
        <issuerTradingSymbol>ESTA</issuerTradingSymbol>
        <issuerForeignTradingSymbol></issuerForeignTradingSymbol>
    </issuer>

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001863404</rptOwnerCik>
            <rptOwnerName>Custin Ann</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <rptOwnerNonUSAddressFlag>false</rptOwnerNonUSAddressFlag>
            <rptOwnerStreet1>C/O MOTIVA USA LLC</rptOwnerStreet1>
            <rptOwnerStreet2>16192 COASTAL HIGHWAY</rptOwnerStreet2>
            <rptOwnerCity>LEWES</rptOwnerCity>
            <rptOwnerState>DE</rptOwnerState>
            <rptOwnerZipCode>19958</rptOwnerZipCode>
            <rptOwnerStateDescription></rptOwnerStateDescription>
        </reportingOwnerAddress>
        <reportingOwnerRelationship>
            <isDirector>1</isDirector>
            <isOfficer>0</isOfficer>
            <isTenPercentOwner>0</isTenPercentOwner>
            <isOther>0</isOther>
        </reportingOwnerRelationship>
    </reportingOwner>

    <aff10b5One>0</aff10b5One>

    <nonDerivativeTable>
        <nonDerivativeTransaction>
            <securityTitle>
                <value>Common Shares</value>
            </securityTitle>
            <transactionDate>
                <value>2026-09-30</value>
            </transactionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>A</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
                <footnoteId id="F1"/>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>301</value>
                </transactionShares>
                <transactionPricePerShare>
                    <value>64.17</value>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>A</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>24626</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>D</value>
                </directOrIndirectOwnership>
            </ownershipNature>
        </nonDerivativeTransaction>
    </nonDerivativeTable>

    <derivativeTable></derivativeTable>

    <footnotes>
        <footnote id="F1">Represents common shares elected to be received in lieu of a quarterly cash retainer payment in accordance with the Reporting Person's prior election under the Issuer's Outside Director Compensation Policy. The common shares were issued pursuant to the Issuer's 2018 Equity Incentive Plan and determined based on the closing price of the Issuer's common shares on the last trading day of the quarter.</footnote>
    </footnotes>

    <remarks></remarks>

    <ownerSignature>
        <signatureName>/s/ Cassandra &quot;Sandra&quot; Harris</signatureName>
        <signatureDate>2026-10-02</signatureDate>
    </ownerSignature>
</ownershipDocument>
