Is Cold Laser Therapy FDA Approved? Here’s What FDA Clearance Really Means
Yes, multiple low-level (“cold”) laser devices are FDA cleared for specific indications. In fact, Erchonia holds 22 FDA 510(k) clearances across low-level laser applications (one of the most extensive clearance portfolios in the category).
This page breaks down what that means, how FDA clearance works, and how Erchonia’s clinical evidence, starting with a landmark neck & shoulder pain study, fits into the bigger picture.
FDA Cleared vs. FDA Approved: What’s the difference?
FDA cleared (510(k))
Most non-invasive therapeutic laser devices come to market through the FDA’s 510(k) clearance process. That process requires manufacturers to notify FDA before marketing a device and allows the agency to determine whether the device is substantially equivalent to a legally marketed device.
FDA approved (PMA)
“FDA approved” usually refers to the Premarket Approval (PMA) pathway, the most stringent route, typically for higher-risk devices. PMA approval is based on FDA’s determination that there’s sufficient valid scientific evidence for safety and effectiveness for the intended use.
Is cold laser therapy FDA approved?
Cold laser therapy is supported by multiple FDA-cleared devices for specific uses. And Erchonia has been a category leader in building that clearance foundation with clinical research and FDA submissions across pain, recovery, dermatology, and aesthetics.
To put that in context:
- FDA clearance is tied to a particular device and a labeled indication.
- Reputable manufacturers can provide the device’s 510(k) number so you can verify it in the FDA database.
Clinical Study: The neck & shoulder pain trial that helped shape FDA clearance
One of the clearest ways to understand why FDA clearance matters is to look at the kind of evidence that supports it.
FDA clearance milestone
In January 2002, the FDA’s 510(k) record shows a decision date of 01/17/2002 for K012580 (Erchonia’s early pain-therapy laser classification), tied to temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
This early clearance is also referenced in published literature discussing FDA clearance for neck and shoulder pain.
This clinical study was designed to evaluate the effectiveness of an Erchonia low-level laser for temporary relief of chronic minor neck and shoulder pain using a Visual Analog Scale (VAS).
- Randomized, double-blind, placebo-controlled
- Multi-site study format consistent with Level 1 trial design expectations for high-quality evidence
- 100 enrolled
- 86 completed (43 active treatment, 43 placebo)
- Change in self-reported pain (VAS) from immediately before to immediately after treatment.
- 65.1% of treated subjects met the individual success criteria
- 11.6% of placebo subjects met the criteria
- The between-group difference exceeded the study’s overall success benchmark
Clinical Study 2 : Erchonia Corporation study submitted to the FDA and given market clearance January 2002.
Abstract
Background: This landmark study together with a companion 2000 study on pain reduction helped the Erchonia low level laser become the first low level laser of any kind to be approved by the FDA as safe and effective for treatment of chronic, minor pain.
Objectives: The purpose of this randomized, double-blind clinical study was to determine the effectiveness of the use of the Erchonia low level laser in providing temporary relief of chronic minor neck and shoulder pain. The primary outcome measure was the change in a subject’s self-reported degree of pain using the Visual Analog Scale (VAS) from immediately prior to the treatment administered to immediately after the treatment.
Methods: 100 subjects were enrolled at three different test sites. A total of 86 subjects completed the study, 43 in each of the test and the placebo group. Subjects were randomly assigned to either the test or placebo group. Subjects in the test group received the actual laser procedure using the specified treatment protocol and subjects in the placebo group received a “fake” laser treatment.
Results: 28 (65.1%) of the test subjects met individual success criteria in improvement of pain, while only 5 (11.6%) of the placebo subjects met this criteria. The overall study success criteria, defined as at least a 30% difference between groups, was exceeded. The actual difference in the proportion of individual subject successes between test and placebo group subjects was 53.5%. Analysis of the primary outcome from the study using a one-tailed z-test found that the proportion of individual successes for subjects in the test group who had received the actual laser treatment was significantly greater than the proportion of individual successes for subjects in the placebo group who received the “fake” treatment.
Conclusion: The Erchonia low level laser is a safe and effective device for single-use temporary pain relief and improvement in range of motion for patients with chronic pain in the neck and shoulder areas originating from the conditions of osteoarthritis, muscle spasms and cervical and thoracic spine strain.
Key Words: Low level laser, low power laser, LLLT, chronic pain, osteoarthritis, muscle spasms, cervical and thoracic spine strain
Why FDA clearance matters for patients (and clinicians)
When a device is FDA cleared for a specific indication, it means the intended use and claims are tied to:
- A defined treatment purpose (example: temporary relief of minor chronic neck/shoulder pain)
- A device that has been reviewed through the appropriate FDA pathway
- Clinical evidence and documentation supporting the labeled indication (which you can often trace via 510(k) records)
That’s very different from vague “laser therapy helps everything” claims, which is why FDA status is worth checking. FDA clearances aren’t just a marketing badge, they’re what allow a manufacturer to make specific claims for specific uses.
In coverage discussing Erchonia’s whole-body musculoskeletal pain clearance, Erchonia’s leadership emphasized the significance of expanding beyond single-body-area indications,
| Year | 510(k) | Device (as listed) | Indication (plain-English summary) |
| 2002 | K012580 | Red single diode | Adjunctive use for temporary relief of minor chronic neck & shoulder pain |
| 2004 | K041139 | Red multi-diode | Laser-assisted liposuction + reduction of pain associated with recovery |
| 2005 | K050672 | Red/Violet multi-diode | Neck/shoulder pain (red) + moderate inflammatory acne vulgaris (violet) |
| 2008 | K072206 | Multi-diode red | Reduction in post-surgery pain after bilateral breast augmentation |
| 2010 | K082609 | MLS Scanner (Zerona) | Non-invasive body contouring and fat reduction |
| 2012 | K121690 | MLS Scanner (Zerona) | Upper arm circumference reduction |
| 2013 | K130922 | Verju Laser System + Massager | Cellulite appearance reduction; body contouring (waist/hips/thighs) |
| 2014 | K132940 | ALLAY (FX 635) | Adjunct to reducing chronic heel pain from plantar fasciitis |
| 2014 | K142042 | SHL (10 Head) | Body contouring of waist/hips/upper abdomen for BMI 30–40 |
| 2015 | K143007 | Zerona-Z6 | OTC: circumference reduction (hips/waist/thighs) |
| 2015 | K150446 | Zerona-Z6 | 6-week protocol circumference reduction (hips/waist/thighs/upper abdomen) |
| 2016 | K153164 | Lunula Laser | Temporary increase of clear nail in onychomycosis |
| 2016 | K162578 | Zerona Z6 OTC | Reduction of body circumference |
| 2018 | K180197 | FX 635 | Relief of minor chronic low back pain + adjunct to plantar fasciitis heel pain |
| 2019 | K190572 | FX 635 | Temporary relief of nociceptive musculoskeletal pain |
| 2019 | K191257 | Red/Violet multi-diode | Neck/shoulder pain (red+violet) + acne vulgaris (violet) |
| 2019 | K192254 | Emerald Laser (SHL) | Reduction of body circumference (BMI up to 40 kg/m²) |
| 2021 | K211186 | Red multi-diode | Adjunctive treatment of postoperative pain |
| 2021 | K212595 | Red/Violet multi-diode | Relief of nociceptive musculoskeletal pain |
| 2022 | K221987 | Green/Violet multi-diode | Neck/shoulder pain + acne vulgaris |
FAQs
Many cold laser devices are FDA cleared (510(k)) for specific indications. “FDA approved” is often used informally online, but “FDA cleared” is typically the more accurate term for these devices.
No. Clearance is device-specific. Always verify the device’s 510(k) number.
FDA clearance supports that a device can be marketed for a specific indication, but individual results can vary. Your provider can help determine whether laser therapy fits your needs and care plan.
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