PHAROS EXCIMER LASER SYSTEM, MODEL EX-308— 510(k) K062963
Substantially EquivalentRa Medical Systems,Inc
FDA 510(k) clearance K062963 for PHAROS EXCIMER LASER SYSTEM, MODEL EX-308, Substantially Equivalent on 2007-04-03. Applicant: Ra Medical Systems,Inc. Device class: 2.
Clearance details
- Applicant
- Ra Medical Systems,Inc
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code GEX
view allMore clearances from Ra Medical Systems,Inc
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K062963
K-number listed on FDA's recall record- Z-1631-2020 — Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region of the electromagnetic spectrum. The UV radiation falls within the range of ultraviolet B (UVB), which is used to treat photo-responsive skin disorders.
- Z-2123-2014 — PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062963.
Data sourced from openFDA. This site is unofficial and independent of the FDA.