200010
III
Renewal application has been received.
Phacoemulsification Units, Cataract Extraction่ถ ๅฃฐไนณๅ่ฃ ็ฝฎ,็ฝๅ ้ๆ้คๆฏ
This profile provides complete Hong Kong MDACS registration information for Phacoemulsification Units, Cataract Extraction. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Phacoemulsification Units, Cataract Extraction
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
17596
Product Code Detail
17596 Phacoemulsification Units, Cataract Extraction
State
Renewal application has been received.
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Bausch + Lomb, Incorporated
Bausch & Lomb Incorporated
United States
็พๅฝ
1400 North Goodman St., Rochester NY 14609, USA
1400ๅๅคๅพทๆผ่ก,็ฝๅๆฏ็นNY 14609,็พๅฝ
Authorised Representative (AR)
22133333
Regulatory Timeline
Registration Date
May 23, 2023
Expiry Date
February 03, 2025
Product Models
Stellaris Elite (Anterior model) (BL11145), Stellaris Elite (Posterior/Combined model) (BL14455), Stellaris Elite (PosteriorCombined with Laser model) (BL15455), 23G Vitesse handpiece 225+ESA (BL5631L), 23G Vitesse handpiece 255TD + ESA (BL5631TD), 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)
ๆๆ็ฒพ่ฑ (ๅๆจกๅ) (BL11145), ๆๆ็ฒพ่ฑ (ๅ็ฝฎ/็ปๅๆจกๅ) (BL14455), ๆๆ็ฒพ่ฑ (ๅ็ฝฎ็ปๅๆฟๅ
ๆจกๅ) (BL15455), 23G ็ปด็นๆฏๆๆบ 225+ESA (BL5631L), 23G ็ปด็นๆฏๆๆบ 255TD + ESA (BL5631TD), 20g ็ป็ไฝๅๅ้คๆฏ (BL5612), 20g ้ซ้ๆฐๅจๅ็ดๅๅฒๆบ (BL5620), 23g ้ซ้ๆฐๅจๅ็ดๅๅฒๆบ (BL5623), 25g ้ซ้ๆฐๅจๅ็ดๅๅฒๆบ (BL5625), 20 ga. ็ป็ไฝๅ้คๆฏๅๅฒๆบ, 7500 cpm (BL5626), 23 ga. ็ป็ไฝๅ้คๅๅฒๆบ, 7500 cpm (BL5627), 25 ga. ๅๅถ็็ป็ไฝๅ้คๅๅฒๆบ, 7500 cpm (SE5625B), 27 ga. ๅๅถ็็ป็ไฝๅ้คๅๅฒๆบ, 7500 cpm (SE5627B), ่ช้ๅบๆตไฝ้ซ็บงๅ
(BL5115-1), ่ช้ๅบๆตไฝๆ ๅๅ
(BL5115-2), ่ช้ๅบๆตไฝๅคๅท้่ฐๆฅ้ซ็บงๅ
(BL5115-3), ่ช้ๅบๆตไฝๅบๆฌๅ
(BL5115-4), 27 ga. ๅๅถ็็ป็ไฝๅๅฒๆบๅๅบไธญๅบๆๆ็ฒพ่ฑๅ
(SE5427MVB), 25 ga. ๅๅถ็็ป็ๅๅฒๆบๅไธญๅบๆๆ็ฒพ่ฑๅ
(SE5425MVB), 25 ga. ๅๅถ็็ป็ๅๅฒๆบๅๅฎฝๅบๆๆ็ฒพ่ฑๅ
(SE5425WVB), 27 ga. ๅๅถ็็ป็ๅๅฒๆบ็ปๅไธญๅบๆๆ็ฒพ่ฑๅ
(SE5527MVB), 25 ga. ๅๅถ็็ป็ๅๅฒๆบ็ปๅไธญๅบๆๆ็ฒพ่ฑๅ
(SE5525MVB), 25 ga. ๅๅ็็ป็ๅๅฒๆบ็ปๅๅฎฝ่งๅบๆๆ็ฒพ่ฑๅ
(SE5525WVB), 2.4 ๆฏซ็ฑณๅฅ็ญ,็จไบ BL3318 ๅ BL3420 (BL3124S)