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LCS AKS Scleral Contact Lenses - HSA Registration DE0510407

Access comprehensive regulatory information for LCS AKS Scleral Contact Lenses in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510407 and owned by LCS. The device was registered on February 28, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0510407
LCS AKS Scleral Contact Lenses
HSA Registration Number: DE0510407
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Product Description

Scleral lenses are designed for the following intended use: • Irregular corneas: Keratoconus, Pellucid Marginal degeneration, Corneal transplant with transparent but irregular cornea, Strong and/or irregular astigmatism, Corneal scars, High ametropia. • Alteration of corneal surface: Dry eye, Lyell or Stevens Johnson syndromes, Aftermath of eye burns, Terrien degeneration (marginal corneal ectasia), Chronic conjunctivitis with corneal epithelial destruction, Bubble Keratopathy. • RGP lenses or hybrid lenses failure. Ophthalmologists or Optometrists are the only professionals who can define scleral lenses type and parameters suitable for pathology and/or correction to the patient.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0510407
Registration Date
February 28, 2025
Change Notification Approval Date
May 14, 2025
Retention Due Date
February 27, 2026
Product Owner
Name
LCS
Short Name
LCS
Address
14 place Gardin, 14000 Caen, FRANCE
Registrant
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Importer
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Model Information
Model Name(s)
AKS [Power: -40.00 to -0.25, +0.25 to +40.00 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS [Power: -40.00 to -0.25, +0.25 to +40.00 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS [Power: -40.00 to -0.25, +0.25 to +40.00 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate [Power: -40.00 to -0.25, +0.25 to +40.00 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate [Power: -40.00 to -0.25, +0.25 to +40.00 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate [Power: -40.00 to -0.25, +0.25 to +40.00 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0/75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0/75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0/75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate-P [Power: -40.00 to -0.25, +0.25 to +40.00 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate-P [Power: -40.00 to -0.25, +0.25 to +40.00 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate-P [Power: -40.00 to -0.25, +0.25 to +40.00 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate-P MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate-P MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate-P MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate-P MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate-P MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS Oblate-P MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D][Oblate: -50 to -500µm] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS-P [Power: -40.00 to -0.25, +0.25 to +40.00 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS-P [Power: -40.00 to -0.25, +0.25 to +40.00 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS-P [Power: -40.00 to -0.25, +0.25 to +40.00 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS-P MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS-P MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS-P MF D [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS-P MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS-P MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)] AKS-P MF N [Power: -40.00 to -0.25, +0.25 to +40.00 D][Additions: +0.75 to 3.50 D] [Pack size: 1 or 2 Mailer per carton box (1 lens/mailer)]
Model Identifier(s)
AKS [Colour: Colourless + UV Filter] AKS [Colour: Blue + UV Filter] AKS [Colour: Colourless + UV Filter] AKS MF D [Colour: Colourless + UV Filter] AKS MF D [Colour: Blue + UV Filter] AKS MF D [Colour: Colourless + UV Filter] AKS MF N [Colour: Colourless + UV Filter] AKS MF N [Colour: Blue + UV Filter] AKS MF N [Colour: Colourless + UV Filter] AKS Oblate [Colour: Colourless + UV Filter] AKS Oblate [Colour: Blue + UV Filter] AKS Oblate [Colour: Colourless + UV Filter] AKS Oblate MF D [Colour: Colourless + UV Filter] AKS Oblate MF D [Colour: Blue + UV Filter] AKS Oblate MF D [Colour: Colourless + UV Filter] AKS Oblate MF N [Colour: Colourless + UV Filter] AKS Oblate MF N [Colour: Blue + UV Filter] AKS Oblate MF N [Colour: Colourless + UV Filter] AKS Oblate-P [Colour: Colourless + UV Filter] AKS Oblate-P [Colour: Blue + UV Filter] AKS Oblate-P [Colour: Colourless + UV Filter] AKS Oblate-P MF D [Colour: Colourless + UV Filter] AKS Oblate-P MF D [Colour: Blue + UV Filter] AKS Oblate-P MF D [Colour: Colourless + UV Filter] AKS Oblate-P MF N [Colour: Colourless + UV Filter] AKS Oblate-P MF N [Colour: Blue + UV Filter] AKS Oblate-P MF N [Colour: Colourless + UV Filter] AKS-P [Colour: Colourless + UV Filter] AKS-P [Colour: Blue + UV Filter] AKS-P [Colour: Colourless + UV Filter] AKS-P MF D [Colour: Colourless + UV Filter] AKS-P MF D [Colour: Blue + UV Filter] AKS-P MF D [Colour: Colourless + UV Filter] AKS-P MF N [Colour: Colourless + UV Filter] AKS-P MF N [Colour: Blue + UV Filter] AKS-P MF N [Colour: Colourless + UV Filter]