Applicant profileMacroLux Medical Technology Co., Ltd.
United StatesShenzhen, CN7 FDA 510(k) clearances
7
Total clearances
5
Unique product codes
Jan 2024
Earliest clearance
Jul 2026
Latest clearance
Company details
- Location
- Shenzhen, CN
Regulatory footprint
Search MacroLux Medical Technology Co., Ltd. across other regulatory registries
Thailand
European Union
Colombia
Vietnam
South Korea
EcuadorDevice class distribution
Clearances by device class
Class 2100.0% of total7 clearances
Recent clearances
Latest 10 FDA 510(k) clearances
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
Jul 20, 2026
- K-Number
- K260516
- Class
- 2
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
Apr 08, 2026
- K-Number
- K260420
- Class
- 2
CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)
Jun 02, 2025
- K-Number
- K250452
- Class
- 2
SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
Aug 16, 2024
- K-Number
- K240978
- Class
- 2
BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)
Jun 10, 2024
- K-Number
- K240283
- Class
- 2
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
Apr 05, 2024
- K-Number
- K233779
- Class
- 2
CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)
Jan 11, 2024
- K-Number
- K231774
- Class
- 2
About this profile
Explore comprehensive applicant profile for MacroLux Medical Technology Co., Ltd. through Pure Global AI's free USA medical device database. This company has 7 FDA 510(k) clearances across 5 unique product codes. Their regulatory history spans from Jan 11, 2024 to Jul 20, 2026.
This page provides detailed insights including recent clearances, device class distribution (Class 2: 7), and complete regulatory timeline from the official FDA OpenFDA database. Pure Global AI offers free access to FDA 510(k) clearances from 1976 to present.