FDA.reportPublic FDA data

LENSTEC, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10631993001659659LENSTEC, INC.1Y2026-01-011765 Commerce Ave N Saint Petersburg FL US 33716

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00844369016858I9011S - Push Injector, titanium1-866-536-7832feedback@lenstec.com
00844369018944LC16 - Box of 10 1.6mm LC16 injector cartridges1-866-536-7832feedback@lenstec.com
00844369018968LC24 - Box of 10 2.4mm LC24 injector cartridges1-866-536-7832feedback@lenstec.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
775681151146136P200020SBL-3 Multifocal Intraocular LensMFK2022-07-22
775681032075747P090022LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENSHQL2010-04-12
775681807188643K161776Lenstec LC Injection systemMSS2016-11-29
775681907057736K063802LENSTEC LC INJECTION SYSTEMMSS2007-05-07
775681548634745K060533LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEMMSS2006-04-14
775681086859186K050638LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSESMSS2005-05-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MSS42016-11-29
MFK 12022-07-22
HQL12010-04-12

PMA#

SBL-3 Multifocal Intraocular Lens

2022-11-17

Lenstec, Inc.1765 Commerce Avenue Northst. Petersburg, FL 33716 PMA NumberP200020 Supplement NumberS002 Date Received10/20/2022 Decision Date11/17/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplemen...

SBL-3 Intraocular Lens

2022-09-16

Lenstec, Inc.1765 Commerce Avenue Northst. Petersburg, FL 33716 PMA NumberP200020 Supplement NumberS001 Date Received08/18/2022 Decision Date09/16/2022 Product Code MFK  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplemen...

SBL-3 Multifocal Intraocular Lens

2022-07-22

Lenstec, Inc.1765 Commerce Avenue Northst. Petersburg, FL 33716 PMA NumberP200020 Date Received03/16/2020 Decision Date07/22/2022 Product Code MFK  Advisory Committee Ophthalmic Clinical TrialsNCT02487160 Expedited Review Granted? No

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PMN#

GUDID#

80 records. Showing 1-40. Next