Luxe™ 2.5 Semi-Custom Loupe
Luxe™ 2.5 Semi-custom loupe demo bag with 9 demo loupes: Model No. DI Number Device Description 922537-1 00850036373377 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst…
Luxe™ 2.5 Semi-custom loupe demo bag with 9 demo loupes: Model No. DI Number Device Description 922537-1 00850036373377 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, short WD, demo only 922537-2 00850036373384 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, regular WD, demo only 922537-3 00850036373391 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic amethyst frame, near PD, long WD, demo only 922538-1 00850036373407 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, short WD, demo only 922538-2 00850036373414 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, regular WD, demo only 922538-3 00850036373421 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, iconic slate frame, regular PD, long WD, demo only 922539-1 00850036373438 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, short WD, demo only 922539-2 00850036373445 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, regular WD, demo only 922539-3 00850036373452 Luxe™ Semi-custom loupe with Luxe™ 2.5 plano oculars, sport black frame, wide PD, long WD, demo only
Who Else Makes It
Concentrated in Guangdong (4), Guangxi (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Guangxi Ehall Medical Technology Co., Ltd. | Nanning | Guangxi | Manufacturer | 17 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
Showing 12 of 15. All 15 manufacturers in China registered for Loupe, Diagnostic/Surgical
Record
| Listed by | Metrex Research, United States |
|---|---|
| FDA product code | FSP |
| Device type | Loupe, Diagnostic/Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-02-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Store at Temperature of -4F to 104F (-20C to +40C); Relative Humidity of 10% to 85%; Atmospheric Pressure of 0.5 atm to |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 922539-2 | In distribution | |
| 910172-2 | In distribution | |
| 910168-3 | In distribution | |
| 922539-3 | In distribution | |
| 922537-1 | In distribution | |
| 910167-2 | In distribution | |
| 910173-1 | In distribution | |
| 910168-1 | In distribution | |
| 910171-3 | In distribution | |
| 910165-3 | In distribution | |
| 922539-1 | In distribution | |
| 910165-2 | In distribution | |
| 910169-1 | In distribution | |
| 910171-2 | In distribution | |
| 922464-2 | In distribution | |
| 910167-3 | In distribution | |
| 910166-3 | In distribution | |
| 910172-1 | In distribution | |
| 922537-3 | In distribution | |
| 922538-2 | In distribution | |
| 910171-1 | In distribution | |
| 910169-2 | In distribution | |
| 910173-2 | In distribution | |
| 910168-2 | In distribution | |
| 910167-1 | In distribution | |
| .LUXE 2.5.TTL.*, Rx | In distribution | |
| 910166-2 | In distribution | |
| 910172-3 | In distribution | |
| 910170-2 | In distribution | |
| 910170-1 | In distribution | |
| 922537-2 | In distribution | |
| 910170-3 | In distribution | |
| 910165-1 | In distribution | |
| 910173-3 | In distribution | |
| 922538-3 | In distribution | |
| 922538-1 | In distribution | |
| 910166-1 | In distribution | |
| 910169-3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eighteeth | Changzhou Sifary Medical Technology Co., Ltd. | 250 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 57 |
| Enova Illumination | Enova Illumination, Inc | 16 |
| Endeavour MD | Metrex Research | 12 |
| Spark TruColor | Metrex Research | 10 |
| Loupe Carrier | Sontec Instruments, Inc. | 5 |
| High Resolution Binocular Loupes SET | Sontec Instruments, Inc. | 5 |
| Diagnostix™ | American Diagnostic Corp. | 4 |
| XHL Xenon Halogen Bulb | Sontec Instruments, Inc. | 3 |
| LED Loupe Light | Sontec Instruments, Inc. | 3 |
| High Resolution Prismatic Binocular Loupes SET | Sontec Instruments, Inc. | 3 |
| High Resolution Binocular Loupe | Sontec Instruments, Inc. | 3 |
Showing 12 of 183. All products under Loupe, Diagnostic/Surgical
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-04-10 | Class II | Finished device change control | The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to the | 639 units | 2012-11-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.