FDA.reportPublic FDA data

SGP

Primary DI
00830002001015
Brand
SGP
Company
LIFESTYLE CO INC, THE
Model
telefocon A
Device description
Blanks (button blanks for use in the manufacture of RGP contact lenses)Color: Blue, Green, Brown, or GrayNumber of Units
Published
2017-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQDLens, Contact (Other Material) - Daily

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQDLens, Contact (Other Material) - DailyOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P840055009
P840055012
P840055028

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P840055009
P840055012
P840055028

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00830002001015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00830002001015008300020010158300020010150830002001015

GMDN Terms#

Term, Definition table
TermDefinition
Rigid-gas-permeable corrective contact lens, daily-wearA rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. The lens may last for years and is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8006220777lenses@lifestylecompany.com

Regulatory Flags#

DUNS number
946065000
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00830002002012SGP IItelefocon B2017-09-24
00830002003019SGP 3unifocon A2017-09-24
00830002000018PuriLens Plus Preservative Free Saline4 oz. (120 mL) Bottle2021-09-24
00830002000094PuriLens Plus Preservative Free Saline2 oz. (60 mL) Bottle2021-09-24
00830002000032PuriLens Plus Disinfecting System Lens BasketMS0610/H2021-09-24
00830002000049PuriLens Plus Disinfecting System Cleaning ChamberMS0610/H2021-09-24
00830002000056PuriLens Plus Disinfecting System Exchange KitMS0610/H2021-09-24
00830002000063PuriLens Plus Disinfecting SystemMS0610/H2021-09-24
00830002000070PuriLens Plus Disinfecting System 110V AdapterMS0610/H2021-09-24
00830002000087PuriLens Plus Preservative Free Saline4 oz. (120 mL) Bottle2021-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899031699962Hidrocor VerdeSOLOTICA INDUSTRIA E COMERCIO LTDAHQD2026-05-11
00850203008040AcuityACUITY POLYMERS, INC.HQD2025-06-09
00850203008330AcuityACUITY POLYMERS, INC.HQD2025-06-09
00860011844129Custom StableValley Contax, Inc.HQD2025-03-14
00860011844136Custom StableValley Contax, Inc.HQD2025-03-14
06974939049000SDJMASTERVISIONTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049017EyeSpace BespokeTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049024EyeSpace BespokeTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049031EyeSpace ScleralTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
06974939049048EyeSpace ScleralTianjin Mastervision Technology Co., Ltd.HQD2025-01-21
00860011844105Custom Stable Valley Contax, Inc.HQD2024-04-08
00860011844112Custom StableValley Contax, Inc.HQD2024-04-08
B22225Oxfore100Paragon Vision Sciences, Inc.HQD2023-09-18
00865576000249Optimum HR 1.51CONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000256Optimum HR 1.53CONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000270Hybird FSCONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000294Optimum InfiniteCONTAMAC HOLDINGS LIMITEDHQD2020-07-28
00865576000201Optimum ExtraCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000218Optimum ExtremeCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000225Optimum ComfortCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000232Optimum ClassicCONTAMAC HOLDINGS LIMITEDHQD2020-07-22
00865576000287HEXA100CONTAMAC HOLDINGS LIMITEDHQD2020-07-22
B22204Fluoroperm 92Paragon Vision Sciences, Inc.HQD2018-03-23
B22205Fluoroperm 60Paragon Vision Sciences, Inc.HQD2018-03-23
B22206Fluoroperm 30Paragon Vision Sciences, Inc.HQD2018-03-23
B22207Fluoroperm 151Paragon Vision Sciences, Inc.HQD2018-03-23
B22208Paragon HDSParagon Vision Sciences, Inc.HQD2018-03-23
B22209Paragon HDS100Paragon Vision Sciences, Inc.HQD2018-03-23
B22212Paragon ThinParagon Vision Sciences, Inc.HQD2018-03-23
B22211FSA 38Paragon Vision Sciences, Inc.HQD2018-03-16