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Sign in to claim this brandMedical Laser Systems, Inc.
US
Last updated May 23, 2026
What Medical Laser Systems, Inc. makes
Medical Laser Systems, Inc. makes the LuminEx LL Laser System and the LuminEx Infrared Lamp System.
These devices are classified as Class II and are listed in the FDA 510(k) registry; the company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Medical Laser Systems, Inc. make?
Medical Laser Systems, Inc. makes the LuminEx LL Laser System and the LuminEx Infrared Lamp System, as stated in the device data summary. These are the specific products identified for this manufacturer in the provided information.
Where is Medical Laser Systems, Inc. based?
Medical Laser Systems, Inc. is based in the United States, as indicated by the COUNTRY field in the device data and confirmed in the summary section which states the company is based in the United States.
Which regulatory registry lists the devices made by Medical Laser Systems, Inc.?
The devices made by Medical Laser Systems, Inc. are listed in the FDA 510(k) registry, as shown in the LISTED IN field of the device data and reiterated in the summary which confirms the devices are listed in the FDA 510(k) registry.
How are the devices made by Medical Laser Systems, Inc. classified?
The devices made by Medical Laser Systems, Inc. are classified as Class II, as specified in the DEVICE CLASSES field of the device data and supported by the summary which states these devices are classified as Class II.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
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Catalogue (54)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PASCAL Synthesis | Synthesis SLC & ESF 577 | FDA UDI | Class II | Active |
| Head-Up-Display, HUD-1 | Head-Up-Display,HUD-1 | FDA UDI | Class I | Active |
| PASCAL Synthesis | PASCAL Synthesis 532 | FDA UDI | Class II | Active |
| PASCAL Synthesis | Synthesis SLC & ESF 532 | FDA UDI | Class II | Active |
| PACSAL Synthesis | PASCAL Synthesis 532- PA04 | FDA UDI | Class II | Active |
| PACSAL Synthesis | PASCAL Synthesis 577- PA04 | FDA UDI | Class II | Active |
| PASCAL Laser Indirect Ophthalmoscope | LIO for Streamline 577 | FDA UDI | Class II | Active |
| PASCAL Synthesis | Synthesis SLC & ESF 577 | FDA UDI | Class II | Active |
| PASCAL Synthesis | PASCAL Synthesis 577 | FDA UDI | Class II | Active |
| PACSAL Synthesis | PASCAL Synthesis 532- PA04 | FDA UDI | Class II | Active |
| PASCAL Synthesis | PASCAL Synthesis 577 | FDA UDI | Class II | Active |
| PASCAL Synthesis TwinStar | PASCAL Synthesis 577 /638 | FDA UDI | Class II | Active |
| PASCAL Laser Indirect Ophthalmoscope | LIO for Synthesis 577 | FDA UDI | Class II | Active |
| PASCAL Synthesis | PASCAL Synthesis 532 | FDA UDI | Class II | Active |
| PASCAL Synthesis | PASCAL Synthesis 577 | FDA UDI | Class II | Active |
| PASCAL Laser Indirect Ophthalmoscope | LIO for PASCAL Photocoagulator 532 | FDA UDI | Class II | Active |
| PASCAL Synthesis | Synthesis SLC & ESF 577 | FDA UDI | Class II | Active |
| PASCAL Synthesis TwinStar | PASCAL Synthesis TwinStar (577/638)- PA04 | FDA UDI | Class II | Active |
| PASCAL Synthesis | PASCAL Synthesis 577 | FDA UDI | Class II | Active |
| PASCAL Laser Indirect Ophthalmoscope | LIO for Streamline 532 | FDA UDI | Class II | Active |
| PASCAL Synthesis | PASCAL Synthesis 532 | FDA UDI | Class II | Active |
| PASCAL Synthesis TwinStar | PASCAL Synthesis 577 /638 | FDA UDI | Class II | Active |
| PASCAL Laser Indirect Ophthalmoscope | LIO for Synthesis 532 | FDA UDI | Class II | Active |
| PASCAL Synthesis | PASCAL Synthesis 532 | FDA UDI | Class II | Active |
| PASCAL Synthesis | PASCAL Synthesis 577- PA04 | FDA UDI | Class II | Active |
| PASCAL Synthesis | Synthesis SLC & ESF 532 | FDA UDI | Class II | Active |
| PASCAL Synthesis TwinStar | PASCAL Synthesis TwinStar (577/638)- PA04 | FDA UDI | Class II | Active |
| PASCAL Synthesis | Synthesis SLC & ESF 532 | FDA UDI | Class II | Active |
| Endocoagulator Krs568(tm) Laser | K904700 | FDA 510(k) | Class II | Active |
| PSLT for PASCAL Streamline | K171488 | FDA 510(k) | Class II | Active |
| Model Pc Argon Ion Laser | K921300 | FDA 510(k) | Class II | Active |
| Hgm Argon Ion & Solid Light Laser For Dentistry | K910602 | FDA 510(k) | Class II | Active |
| Model 20 Ky Krypton Yellow Laser | K881940 | FDA 510(k) | Class II | Active |
| Pascal Photocoagulator, Product-Pascal-01 | K043486 | FDA 510(k) | Class II | Active |
| PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | K180402 | FDA 510(k) | Class II | Active |
| Endocoagulator Model 20 Laser & Accessories | K881507 | FDA 510(k) | Class II | Active |
| Luminex Ll Laser System | K063574 | FDA 510(k) | Class II | Active |
| Photcoagulator Kr-568 Laser Spectrum Elite K1 | K911104 | FDA 510(k) | Class I | Active |
| Litespot(tm) Laser Indirect Ophthalmoscope | K914484 | FDA 510(k) | Class II | Active |
| Models 5, 8, 20, 20s Argon Ion Lasers | K912438 | FDA 510(k) | Class II | Active |
| Pascal Synthesis (532nm/577nm) Opthalmic Laser | K123542 | FDA 510(k) | Class II | Active |
| O-020 Laser Indirect Ophthalmoscope | K890787 | FDA 510(k) | Class II | Active |
| Series 1990 Argon Surgical Lasers, E1, E6, E14&E20a | K904342 | FDA 510(k) | Class II | Active |
| Compac A, Elite A, Elite A Plus, Surgica A | K913569 | FDA 510(k) | Class II | Active |
| Air Argon Ion Lasers Various Models | K912628 | FDA 510(k) | Class II | Active |
| Pascal Streamline 577 (with Accessories) | K111108 | FDA 510(k) | Class II | Active |
| F300 Series Contact Fiber Handpieces | K901021 | FDA 510(k) | Class II | Active |
| 5 Mm Irrigation/Aspiration Fiber Probe | K902258 | FDA 510(k) | Class II | Active |
| Hgm Combination Nd:yag & Solid State Green | K910272 | FDA 510(k) | Class II | Active |
| Endoscopic Uses Of The Argon Laser In General Surg | K896314 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 15, 2016 | Z-2405-2016 | — | terminated | Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode. |
| Mar 27, 2012 | Z-1774-2013 | — | terminated | When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment. |