5 Wavelength LED Facemask (TN2508)— 510(k) K260598
Substantially EquivalentiSMART Developments, Ltd.
FDA 510(k) clearance K260598 for 5 Wavelength LED Facemask (TN2508), Substantially Equivalent on 2026-07-24. Applicant: iSMART Developments, Ltd.. Device class: 2.
Clearance details
- Applicant
- iSMART Developments, Ltd.
- Product code
- Code OHS
- 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
- Birmingham, GB
Recent devices under product code OHS
view all- K261407 — XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)
- K261473 — Chromix
- K261052 — LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)
- K260946 — LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
- K254025 — LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
More clearances from iSMART Developments, Ltd.
view allAdverse events under product code OHS
product code OHS- 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.