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Singapore HSA registration DE0510408

LCS Non-Sterile Scleral Contact Lenses (Toric)

Singapore flagSingapore·CLASS B·LCS·Registered February 28, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0510408
Registration Date
February 28, 2025
Retention Due Date
February 27, 2026
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.
Product Owner
Name
LCS
Short Name
LCS
Address
14 place Gardin, 14000 Caen, FRANCE
Registrant
Name
Mandarin Opto-Medic Co Pte Ltd
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Importer
Name
Mandarin Opto-Medic Co Pte Ltd
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Model information
Model Name(s)
AKS ATD AKS ATD MF D AKS ATD MF N AKS ATD-P AKS ATD-P MF D AKS ATD-P MF N AKS Oblate ATD AKS Oblate ATD MF D AKS Oblate ATD MF N AKS Oblate ATD-P AKS Oblate ATD-P MF D AKS Oblate ATD-P MF N AKS Oblate Toric AKS Oblate Toric MF D AKS Oblate Toric MF N AKS Oblate Toric-P AKS Oblate Toric-P MF D AKS Oblate Toric-P MF N AKS Toric AKS Toric MF D AKS Toric MF N AKS Toric-P AKS Toric-P MF D AKS Toric-P MF N
Model Identifier(s)
AKS ATD AKS ATD MF D AKS ATD MF N AKS ATD-P AKS ATD-P MF D AKS ATD-P MF N AKS Oblate ATD AKS Oblate ATD MF D AKS Oblate ATD MF N AKS Oblate ATD-P AKS Oblate ATD-P MF D AKS Oblate ATD-P MF N AKS Oblate Toric AKS Oblate Toric MF D AKS Oblate Toric MF N AKS Oblate Toric-P AKS Oblate Toric-P MF D AKS Oblate Toric-P MF N AKS Toric AKS Toric MF D AKS Toric MF N AKS Toric-P AKS Toric-P MF D AKS Toric-P MF N
About this record

Access comprehensive regulatory information for LCS Non-Sterile Scleral Contact Lenses (Toric) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510408 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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