Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011580044

FEI Number

3011580044

Entity Name

XCELLANCE MEDICAL TECHNOLOGIES PVT. LTD.

City/State/Country

Navi Mumbai Maharashtra, IN

Establishment Address

Shalya Avenue, Plot No. W-237, W-238(A) & W-239, T.T.C. Industrial Area, M.I.D.C., Rabale, Navi Mumbai Maharashtra 400701, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

XcelLance Medical Technologies Pvt. Ltd. (Owner Number: 10057918)

Owner / Operator Contact Address

Shalya Avenue, Plot No. W-237, W-238(A) & W-239, T.T.C., Industrial Area, M.I.D.C., Rabale, Navi Mumbai, IN-MH 400701, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shalya EndoLUX: EndoLUX P Shalya EndoLUX: EndoLUX D Shalya EndoLUX: EndoLUX e Shalya Flex 500 N Shalya Flex 500 Shalya Flex 500 E (without top sliding) Shalya Flex 200 (Advance) Shalya Flex 500 Es (with top sliding) Shalya Flex 200 E Shalya Flex 500 Pro Shalya iLUX Mobile Surgical Light System: iLUX 10 M Shalya iLUX Mobile Surgical Light System: iLUX 40-40 M Shalya iLUX Mobile Surgical Light System: iLUX 10-20 M Shalya iLUX Mobile Surgical Light System: iLUX 20 M Shalya iLUX Mobile Surgical Light System: iLUX 10-10 M Shalya iLUX Mobile Surgical Light System: iLUX 10-40 M Shalya iLUX Mobile Surgical Light System: iLUX 20-40 M Shalya iLUX Mobile Surgical Light System: iLUX 20-20 M Shalya ReCo FHD Shalya ReCo UHD Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 10 O Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 10-40 O Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 10-20 O Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 20-20 O Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 10-10 O Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 20-40 O Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 20 O Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 40-40 O Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 40 O Irrigation Trolley Laparoscopic Trolley Basic ESU Trolley Console Trolley Shalya Integra Argon Trolley Surgical Pendant ICU Pendant Horizontal Pendant Anesthesia Pendant Endoscopy Pendant Hybrid Pendant Shalya iLUX Surgical Light with Camera- Display system: iLUX 20-20 M/W/O/C-D Shalya iLUX Wall Mount Surgical Light System: iLUX 20-40 W Shalya iLUX Surgical Light with Camera- Display system: iLUX 20-40 M/W/O/C-D Shalya iLUX Surgical Light with Camera- Display system: iLUX 40-40 M/W/O/C-D Shalya iLUX Surgical Light with Camera System: iLUX 40 O/C Shalya iLUX Wall Mount Surgical Light System: iLUX 40-40 W Shalya iLUX Surgical Light with Camera- Display system: iLUX 10-20 M/W/O/C-D Shalya iLUX Wall Mount Surgical Light System: iLUX 10-40 W Shalya iLUX Wall Mount Surgical Light System: iLUX 20 W Shalya iLUX Wall Mount Surgical Light System: iLUX 20-20 W Shalya iLUX Wall Mount Surgical Light System: iLUX 10-10 W Shalya iLUX Surgical Light with Camera- Display system: iLUX 10-40 M/W/O/C-D Shalya iLUX Surgical Light with Camera System: iLUX 20 M/W/O/C Shalya iLUX Wall Mount Surgical Light System: iLUX 10 W Shalya iLUX Wall Mount Surgical Light System: iLUX 10-20 W

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2018-06-16
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2023-12-09
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2018-06-18
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2023-12-09
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2018-06-13
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2023-12-09
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2023-12-09
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2018-06-16

Official Correspondent

No official correspondent registered.

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

XcelLance Medical Technologies Pvt. Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011580044. Last updated year: 2026. Please use registration number 3011580044 when referencing this establishment in official correspondence.