Walk into any Hospital and you'll see it immediately. Every single tool, implant, and device has some kind of marking on it. Serial numbers, logos, barcodes.
When you're putting something inside someone's body, or even just touching their skin, you need to know exactly what it is, where it came from, and when it was made.
Unlike printed labels that can peel off or ink that might leach into tissue, laser marks are permanent. They survive autoclaves, years inside the human body, and decades of use.
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The range is pretty incredible when you think about it. A neural probe might be thinner than a human hair, but it still needs a readable serial number. A hip implant weighs several ounces and needs to last 20+ years inside someone's body. The marking has to last just as long.
Then there's all the everyday stuff. Forceps get sterilized hundreds of times. Catheters need batch codes. Even stethoscopes benefit from permanent marking for inventory tracking. Then…don't forget all of the packaging. When a surgeon opens a sterile pouch, the label better match what's inside.
Every device sold in the US needs a Unique Device Identifier (UDI) that the FDA can trace from manufacturing all the way to the patient. Europe has similar rules under MDR.
Why? Three big reasons:
For anything that goes inside the body, traditional ink or adhesive labels are basically banned. The marking has to be permanent and can't leave any residue. Laser marking is often the only option that works and complies with ISO 13485.
Laser marking applies a very focused light to modify a material's surface. Depending on what you're marking and how, you might get discoloration, a photo-chemical change, or actual engraving.
UV lasers are precision tools that easily focus down to 5-7 microns, while some custom setups hit one micron. That's small enough to mark a neural probe without damaging it. In marking applications, however, most UV lasers operate with spot sizes in the 10–20 μm range.
Here are the most common laser marking applications used for medical devices.
Laser etching alters the surface of a medical device, removing a minimal amount of material to make its mark. Etching happens at very low depths, so there’s no real impact on the functionality or integrity of the device itself (in most cases).
The process uses controlled heat or ablation to vaporize microscopic amounts of material, creating contrast through slight surface texture changes.
Unlike engraving, etching doesn't create significantly raised or recessed areas. Instead, it produces a subtle surface modification that's easily readable under normal lighting conditions.
The minimal material removal means critical dimensions remain practically unchanged, making it ideal for precision components where micron-level changes do not affect performance.
Etching can also be used to create a surface texture to meet roughness specs. For example, an implantable that needs to graft to bone requires a specific amount of texture.
| Uses Cases | Materials | Benefits |
|---|---|---|
| Marking surgical instruments with serial numbers or barcodes | Stainless steel | Minimal impact on part integrity |
| Traceability codes on orthopedic screws and plates | Titanium | High-contrast, permanent marks |
| Adding surface roughness for implant integration | Ceramics, Metals | Can meet both identification and surface roughness requirements |
Laser engraving removes material from the surface at a greater depth, typically 0.002" to 0.005" or more. It creates recessed marks that can be detected when you run your hand over them, and has high durability, wear resistance, and readability. However, engraving is not a preferred method of marking for the medical applications, as it is too rough and potentially dangerous to the patients.
Engraving parameters can be adjusted to control depth, width, and edge quality. Deeper engravings provide better durability but may create stress concentrations in load-bearing components, and/or sharp edges.
| Use Cases | Materials | Benefits |
|---|---|---|
| Permanent branding on metal housings for diagnostic equipment | Aluminum & Titanium | Readable even after decades of use |
| Marking orthopedic implants for lifetime traceability | Titanium, Cobalt-chrome | Ideal for high-stress environments. Texture for bone grafting |
With laser annealing, heat is focused to change the color or composition of the surface without causing damage. This process produces a visible mark through the formation of an oxide layer or other molecular changes without removing material. One of the most common results is a medium-gray to black mark on stainless steel.
The key advantage is that while changing the surface color, annealing doesn't damage the material's polish, surface finish, or dimensional accuracy. This makes it ideal for applications where maintaining the original surface properties is critical, such as fluid-contact surfaces or precision-machined components.
The process works by heating a very thin surface layer to a controlled temperature that triggers color changes without melting the substrate. Stainless steel forms dark oxides, while titanium can produce a range of colors depending on temperature control.
| Use Cases | Materials | Benefits |
|---|---|---|
| UDI marking on polished stainless-steel surgical instruments | Stainless steel | No dimensional changes to the part |
| Color-coded identification on titanium implants | Titanium | Maintains corrosion resistance and polish |
| Cosmetic branding without altering surface finish | Nickel-based alloys | High-contrast marks without material removal |
While not impacting the surface shine is desirable in some applications, it’s a challenge in others. In some cases, this can make it difficult to read the mark without changing the angle of the device to avoid reflections.
Laser ablation uses a highly directed beam to break down chemical bonds at a molecular level with a minimal heat-affected zone (HAZ), making it ideal for heat-sensitive materials. By precisely controlling photon energy, ablation can remove material layer by layer with exceptional accuracy.
Unlike thermal processes, ablation occurs so quickly (nanosecond to femtosecond pulses) that heat doesn't have time to conduct into surrounding material. This cold laser process is particularly valuable for polymers, coated materials, and composite structures where thermal damage could compromise material properties or delaminate layers.
Ablation also excels at creating fine features with sharp, clean edges. The process can selectively remove specific layers in multi-layer materials, such as removing a colored surface layer to reveal a contrasting substrate underneath.
| Use Cases | Materials | Benefits |
|---|---|---|
| Removing coatings from metal implants to reveal contrasting substrate | PEEK, ABS, and other medical-grade polymers | Minimal thermal impact on surrounding material |
| Creating high-precision marks on catheters and tubing without deformation | Coated metals | Extremely precise for micro-features |
| Layer removal in composite or coated medical housing | Multi-layer films and packaging materials | Ideal for delicate or layered materials |
What you're marking matters more than you might think:
The key is understanding how your specific material behaves under different laser wavelengths and parameters, and how that mark needs to perform over the device's lifetime.
Here's something that surprises people: the laser manufacturer isn't responsible for compliance. That's all on the medical device company. They have to test everything, document that the marking works under real conditions (autoclaving, radiation, body fluids), and prove it to the FDA.
Once you get approval, you're locked in. Change anything (software updates, different laser model, new settings) and you might need to revalidate. That can take months or years. This is why you'll still find manufacturers running DOS-based systems or Windows XP machines. Not because they're behind the times, but because changing would mean starting the approval process over. Stability in the manufacturing process wins every time in this industry.
Medical Devices keep shrinking. Neural interfaces, micro-stents, tiny sensors: they all need marks. Modern laser systems routinely work with 5-10 micron spot sizes. That means data matrix codes as small as 100x100 microns and character heights under 100 microns.
But lasers aren't just for marking anymore. Need a 50-micron hole in a catheter for drug delivery? Laser-drilled. Want to cut and mark a stent in one operation? Femtosecond lasers make it possible.
The same qualities that make lasers good for marking make them perfect for micromachining, too.
Medical laser systems have to meet serious cleanroom standards. Most are adapted from semiconductor equipment and include:
Any time you ablate material, the part needs post-cleaning before use. Contamination risk is real, especially for implantables.
In high-volume operations like catheter manufacturing, where hundreds of millions are produced every year, speed matters. But…accuracy comes first. Need more throughput? Manufacturers typically add another identical system, instead of redesigning their process to use high-power or faster lasers.
Manufacturers have options depending on their needs:
Some companies mark both the device and packaging with the same laser system, creating a complete traceability loop.
When comparing laser manufacturers, look for a company that has an in-house testing lab and can run studies on your particular materials and processes to find you the right fit.
In medical manufacturing, every mark has to count. It needs to be precise, permanent, and legally defensible. The right laser system is one that fits your material, your workflow, and regulatory requirements without cutting corners.
Need a laser for a medical marking application?
Alex Laymon became President and Director of DPSS Lasers (now a Laserax company) in 1998. He previously served as the Vice President of Engineering at LiCONiX, following a series of technical positions that included Engineering Manager and Senior Laser Engineer. Mr. Laymon received his B.S. in Engineering Physics and his M.B.A. at Santa Clara University. His decades of expertise in UV lasers now contribute to Laserax's mission to shape the future of high-precision laser solutions.
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