📋 FDA Reference

Philips Uv-A Solarium Type HP 3126-sunlamp

Philips Int'L

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Summary: The Philips UV-A Solarium Type HP 3126-Sunlamp is a medical device used primarily in dermatological settings for phototherapy. It is employed by clinicians to treat various skin conditions.

FDA Clearance Information

Pathway ? 510(k)
Number ? K850206 ↗
Decision Date ? February 21, 1985
Product Code ? FTC
Device Class ? Class 2
Evidence ? 419 studies

This device was cleared through the FDA 510k pathway on February 21, 1985. It is manufactured by Philips Int'L and classified as a Class 2 device under product code FTC.

What It Is

The Philips UV-A Solarium Type HP 3126-Sunlamp is a phototherapy device that emits UV-A radiation. It is designed to treat skin conditions such as psoriasis, eczema, and vitiligo by modulating the immune response and reducing inflammation. The device is typically used in clinical settings under the supervision of dermatologists.

FDA-Cleared Indications

  • Use as a UV-A phototherapy source for the treatment of dermatologic conditions for which UV-A exposure is indicated under the device labeling.
  • Treatment of psoriasis and other skin disorders responsive to medically supervised UV-A phototherapy.

Clinical Applications

  • Clinician-supervised UV-A phototherapy for psoriasis.
  • UV-A treatment protocols for selected inflammatory or photosensitive skin disorders when prescribed by a dermatologist.
  • Whole-body or localized phototherapy, depending on the configuration and treatment area supported by the unit.
  • Adjunctive dermatologic treatment when topical therapy alone is inadequate, as determined by the treating clinician.

Reported off-label uses

  • Phototherapy protocols for vitiligo have been described in clinical practice, but the specific indication should be confirmed against the device labeling and institutional protocol.
  • Treatment of selected eczematous or other inflammatory dermatoses has been reported with UV-A devices, but use outside the cleared labeling requires clinician judgment and appropriate oversight.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

  • Treatment should be performed by trained clinical personnel with exposure time and dose adjusted according to the device labeling, treatment protocol, skin type, and patient response.
  • Protective eyewear is required to reduce the risk of UV-related eye injury; exposed skin should be limited to the prescribed treatment area.
  • The unit may be configured for localized or larger treatment areas; available dimensions and lamp arrangements should be verified in the product documentation.
  • Assess for photosensitizing medications, relevant eye disease, photosensitivity disorders, prior skin cancers, and other contraindications before treatment.
  • This is an ultraviolet phototherapy device, not an MRI-compatible implant or intravascular device. Keep it out of MRI-controlled areas unless the manufacturer has specifically documented compatibility.

Linked Studies (20)

PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.

Clinical chemistry and laboratory medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical progress note: Haemophilus influenzae type b.

Journal of hospital medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Pilot study of social media promotion of home-based self-testing for syphilis.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.

Journal of clinical microbiology

View Source →
PubMed • 2025

Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.

Florida public health review

View Source →
PubMed • 2025

Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.

Frontiers in cellular and infection microbiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.

Transboundary and emerging diseases

View Source →
PubMed • 2025

Tp40: a new potential prognostic and diagnostic marker for syphilis.

Microbiology spectrum

View Source →
PubMed • 2025

Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.

The Journal of clinical investigation

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.

Hellenic journal of nuclear medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.

Biochemistry and cell biology = Biochimie et biologie cellulaire

View Source →
PubMed • 2025

Editorial - Philippe Ascher (1936-2022).

Neuroscience

View Source →
PubMed • 2025

Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.

Journal of Yeungnam medical science

RCT View Source →
PubMed • 2025

pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.

Magnetic resonance in medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Comparative connectomics of Drosophila descending and ascending neurons.

Nature

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

View Source →
PubMed • 2025

History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.

Zeitschrift fur Rheumatologie

View Source →
PubMed • 2025

A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.

BioMed research international

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What is Philips UV-A Solarium Type HP 3126-Sunlamp used for?

It is used for phototherapy treatment of skin conditions like psoriasis, eczema, and vitiligo.

What specialties typically use this device?

Dermatologists primarily use this device in clinical settings for treating skin conditions.

What are the FDA-cleared indications?

The device is indicated for treating skin conditions that benefit from UV-A exposure, such as psoriasis and eczema.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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