📋 FDA Reference
Philips Uv-A Sdarium Type HP 3148 Cfr 21 Sunlamp
Philips Int'L
Summary: The Philips UV-A Sdarium Type HP 3148 is a medical sunlamp used for therapeutic purposes, primarily by dermatologists. It is designed to treat skin conditions requiring UV-A exposure.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K851533 ↗
Decision Date ?
May 1, 1985
Product Code ?
FTC
Device Class ?
Class 2
Evidence ?
419 studies
The Philips UV-A Sdarium Type HP 3148 was cleared through the FDA 510(k) pathway on May 1, 1985. Manufactured by Philips Int'L, it is classified as a Class 2 device under product code FTC.
What It Is
The Philips UV-A Sdarium Type HP 3148 is a specialized sunlamp that emits UV-A radiation. It is used in phototherapy to treat various dermatological conditions. The device operates by delivering controlled doses of UV-A light, which can help in managing conditions like psoriasis and vitiligo by slowing down the growth of affected skin cells.
FDA-Cleared Indications
- Therapeutic exposure of the skin to ultraviolet-A radiation.
- Use in the treatment of dermatologic conditions responsive to UV-A phototherapy, according to the device labeling and clinical protocol.
Clinical Applications
- Controlled UV-A phototherapy for selected skin disorders in a dermatology clinic or hospital.
- Treatment sessions in which a clinician controls exposure time and dose.
- Phototherapy for patients whose condition is evaluated as responsive to UV-A radiation.
Practical Considerations
- The device is a UV-A phototherapy lamp, not an implantable device or an endovascular device.
- Treatment requires a prescribed exposure schedule, dose monitoring, and appropriate equipment maintenance or calibration.
- Patients and staff should follow the clinical protocol for eye protection and shielding of areas not intended for treatment.
- UV-A exposure may be inappropriate or require special precautions in people with photosensitivity, certain medications, eye disease, or a history of skin cancer; the treating clinician should review these risks.
- MRI compatibility is generally not applicable to this external lamp, but the device should not be brought into an MRI room unless the manufacturer and facility have specifically cleared it for that environment.
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
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 Sdarium Type HP 3148 used for?
It is used for phototherapy in treating skin conditions like psoriasis and vitiligo.
What specialties typically use this device?
Dermatologists and skin specialists commonly use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for therapeutic use in skin conditions responsive to UV-A light, such as psoriasis and vitiligo.
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.