PDT-FACE— 510(k) K192295
Substantially EquivalentBeijing Adss Development Co., Ltd.
FDA 510(k) clearance K192295 for PDT-FACE, Substantially Equivalent on 2020-05-01. Applicant: Beijing Adss Development Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Beijing Adss Development Co., Ltd.
- Product code
- Code OLP
- 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
- Beijing, CN
Recent devices under product code OLP
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- K231896 — Diode Laser Therapy System
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- K220268 — Picosecond Laser System (Model PS10-A and PS10-B)
Adverse events under product code OLP
product code OLP- Other
- 1
- Total
- 1
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.