FEI 3008699663

Transdermal Cap Inc Dba Lasercap Company

26 Alpha Park, Highland Heights, OH, US

Establishment typeManufactureManufacture Medical Device

Registered product codes

1 product codes

0 on file

No MDR events on file for this firm name.

0 on file

No recalls on file for this firm name.

Matched by FEI 3008699663.

5 on file

Voluntary Action Indicated (VAI)Jun 6, 2025
Compliance: Devices · Citations posted
No Action Indicated (NAI)Jun 6, 2025
Postmarket Assurance: Devices · Citations posted
Voluntary Action Indicated (VAI)Jun 6, 2025
Radiation Control and Health Safety Act · Citations posted
Voluntary Action Indicated (VAI)Mar 26, 2024
Compliance: Devices · Citations posted
No Action Indicated (NAI)Mar 26, 2024
Postmarket Assurance: Devices · Citations posted

15 on file

Top cited requirements

21 CFR 820.198(c)Jun 6, 2025
Investigation of device failures
21 CFR 1002.13Jun 6, 2025
Failure to submit
21 CFR 1010.3(a)(2)Jun 6, 2025
ID label lacks place, month & year of manufacture
21 CFR 1040.10(h)(2)(i)Jun 6, 2025
Reproduction of affixed information
21 CFR 820.20(c)Mar 26, 2024
Management review - defined interval, sufficient frequency
21 CFR 820.22Mar 26, 2024
Quality Audit/Reaudit - conducted
21 CFR 820.30(g)Mar 26, 2024
Design Validation - Risk analysis not performed/inadequate
21 CFR 820.30(j)Mar 26, 2024
Design history file
21 CFR 820.50(a)(1)Mar 26, 2024
Evaluation and Selection, Suppliers, Contractors, etc.
21 CFR 820.50(a)(2)Mar 26, 2024
Supplier oversight
21 CFR 820.50(a)(3)Mar 26, 2024
Acceptable supplier records, inadequate records
21 CFR 820.72(a)Mar 26, 2024
Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.90(a)Mar 26, 2024
Nonconforming product control
21 CFR 820.100(b)Mar 26, 2024
Documentation
21 CFR 820.198(c)Mar 26, 2024
Investigation of device failures

0 on file

No warning letters or injunctions on file for this FEI number.

0 on file

No import refusals on file for this FEI number.