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

    <schemaVersion>X0508</schemaVersion>

    <documentType>4</documentType>

    <periodOfReport>2025-08-03</periodOfReport>

    <notSubjectToSection16>0</notSubjectToSection16>

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

    <reportingOwner>
        <reportingOwnerId>
            <rptOwnerCik>0001742429</rptOwnerCik>
            <rptOwnerName>Chacon Quiros Juan Jose</rptOwnerName>
        </reportingOwnerId>
        <reportingOwnerAddress>
            <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>2025-08-03</value>
            </transactionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>A</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
                <footnoteId id="F1"/>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>10285</value>
                </transactionShares>
                <transactionPricePerShare>
                    <value>0</value>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>A</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>224433</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>D</value>
                </directOrIndirectOwnership>
            </ownershipNature>
        </nonDerivativeTransaction>
        <nonDerivativeHolding>
            <securityTitle>
                <value>Common Shares</value>
            </securityTitle>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>1078264</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>I</value>
                </directOrIndirectOwnership>
                <natureOfOwnership>
                    <value>See Footnote</value>
                    <footnoteId id="F2"/>
                </natureOfOwnership>
            </ownershipNature>
        </nonDerivativeHolding>
    </nonDerivativeTable>

    <derivativeTable>
        <derivativeTransaction>
            <securityTitle>
                <value>Stock Option (Right to buy)</value>
            </securityTitle>
            <conversionOrExercisePrice>
                <value>36.46</value>
            </conversionOrExercisePrice>
            <transactionDate>
                <value>2025-08-03</value>
            </transactionDate>
            <transactionCoding>
                <transactionFormType>4</transactionFormType>
                <transactionCode>A</transactionCode>
                <equitySwapInvolved>0</equitySwapInvolved>
                <footnoteId id="F1"/>
            </transactionCoding>
            <transactionAmounts>
                <transactionShares>
                    <value>14906</value>
                </transactionShares>
                <transactionPricePerShare>
                    <value>0</value>
                </transactionPricePerShare>
                <transactionAcquiredDisposedCode>
                    <value>A</value>
                </transactionAcquiredDisposedCode>
            </transactionAmounts>
            <exerciseDate>
                <value>2026-06-01</value>
                <footnoteId id="F3"/>
            </exerciseDate>
            <expirationDate>
                <value>2035-05-14</value>
            </expirationDate>
            <underlyingSecurity>
                <underlyingSecurityTitle>
                    <value>Common Shares</value>
                </underlyingSecurityTitle>
                <underlyingSecurityShares>
                    <value>14906</value>
                </underlyingSecurityShares>
            </underlyingSecurity>
            <postTransactionAmounts>
                <sharesOwnedFollowingTransaction>
                    <value>14906</value>
                </sharesOwnedFollowingTransaction>
            </postTransactionAmounts>
            <ownershipNature>
                <directOrIndirectOwnership>
                    <value>D</value>
                </directOrIndirectOwnership>
            </ownershipNature>
        </derivativeTransaction>
    </derivativeTable>

    <footnotes>
        <footnote id="F1">Represents an award of stock units under the Issuer's 2018 Equity Incentive Plan. One-fourth of the shares subject to the award shall vest on June 1, 2026 and each one-year anniversary thereafter, subject to the Reporting Person continuing as a service provider through such date. The grant was contingent upon execution of a post-employment agreement, which was signed on August 3, 2025. Concurrently, the Reporting Person entered into a consulting agreement effective June 1, 2025.</footnote>
        <footnote id="F2">The shares are held by Sariel Group Ltd. The Reporting Person is a shareholder of Sariel Group Ltd and has voting and dispositive power over the shares owned by Sariel Group Ltd. The Reporting
Person disclaims beneficial ownership of the shares held by Sariel Group Ltd, except to the extent of his pecuniary interest therein.</footnote>
        <footnote id="F3">One-fourth of the shares subject to the option shall vest on June 1, 2026 and each one-year anniversary thereafter, subject to the Reporting Person continuing as a service provider through each
such date.</footnote>
    </footnotes>

    <remarks></remarks>

    <ownerSignature>
        <signatureName>/s/ Rajbir S. Denhoy, Chief Financial Officer, by power of attorney</signatureName>
        <signatureDate>2026-01-09</signatureDate>
    </ownerSignature>
</ownershipDocument>
