Medical Device Division · registration 200010Active

Bausch + Lomb

Name: Bausch + Lomb — Medical Device Division 200010
Creator: Bausch & Lomb Incorporated
Keywords: Bausch + Lomb, Bausch + Lomb, 200010, Phacoemulsification Units, Cataract Extraction, Medical Device Division

Hong KongPhacoemulsification Units, Cataract ExtractionClass IIIBausch & Lomb Incorporated

Verified

Official record identity

MDACS listing number: 200010
Model name: Stellaris Elite (Anterior model) (BL11145), Stellaris Elite (Posterior/Combined model) (BL14455), Stellaris Elite (PosteriorCombined with Laser model) (BL15455), 20g Anterior Vitrectomy (BL5612), 20g High Speed Pneu Vit Cutter (BL5620), 23g High Speed Pneu Vit Cutter (BL5623), 25g High Speed Pneu Vit Cutter (BL5625), 20 ga. Vitrectomy Cutter, 7500 cpm (BL5626), 23 ga. Vitrectomy Cutter, 7500 cpm (BL5627), 25 ga. Bi-Blade Vitrectomy Cutter, 7500 cpm (SE5625B), 27 ga. Bi-Blade Vitrectomy Cutter, 7500 cpm (SE5627B), Adaptive Fluidics Premium Pack (BL5115-1), Adaptive Fluidics Standard Pack (BL5115-2), Adaptive Fluidics MICS Premium Pack (BL5115-3), Adaptive Fluidics Basic Pack (BL5115-4), 27 ga. Bi-Blade Vitreous Cutter Posterior Mid-Field Stellaris Elite Pack (SE5427MVB), 25 ga. Bi-Blade Vitreous Cutter Posterior Mid-Field Stellaris Elite Pack (SE5425MVB), 25 ga. Bi-BladVitreous Cutter Posterior Wide-Field Stellaris Elite Pack (SE5425WVB), 27 ga. Bi-Blade Vitreous Cutter Combined Mid-Field Stellaris Elite Pack (SE5527MVB), 25 ga. Bi-Blade Vitreous Cutter Combined Mid-Field Stellaris Elite Pack (SE5525MVB), 25 ga. Bi-Blade Vitreous Cutter Combined Wide-Field Stellaris Elite Pack (SE5525WVB), 2.4mm Sleeve for BL3318 and BL3420 (BL3124S)
Registration date: June 18, 2025
Expiry date: February 02, 2030
Status: Active

Classification

Risk class: Class III
Published category: Phacoemulsification Units, Cataract Extraction

Published parties

Registrant / registration holder: Bausch & Lomb (Hong Kong) Ltd.
Manufacturer: Bausch & Lomb Incorporated

Official description

Phacoemulsification Units, Cataract Extraction

Additional source fields

AMD nomenclature code: 17596
Traditional Chinese local responsible person: 博士倫(香港)有限公司
Local responsible person phone: 22133333
Published manufacturer address: 1400 North Goodman Street, Rochester, New York, 14609, USA
Revision number: c

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.