PowerLaser Basic 500 Cool Grey 35052
PowerLaser Basic 500 Cool Grey 35052, a musculoskeletal/physical therapy laser (FDA Class II; FDA product code ILY, Lamp, Infrared, Therapeutic Heating) made by Powermedic ApS, was listed in FDA GUDID on 13 Jun 2023 (UDI-DI 57135920350527); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number57135920350527 | Date13 Jun 2023 | StatusListed |
Official records
- AccessGUDID record 57135920350527
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- PowerLaser Basic 500 Cool Grey
- Generic name
- Musculoskeletal/physical therapy laser, home-use
- Model / reference
- 35052
- Primary DI / UDI-DI
- 57135920350527
- FDA product code
- ILY
- GMDN term
- Musculoskeletal/physical therapy laser, home-use
- Device class
- Class II
- Regulation number
- 890.5500
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code ILY (Lamp, Infrared, Therapeutic Heating).
- AXON IR Heat Lamp by CRYSTAL MEDTECH, LLC
- DYNATRON X3, DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE by Dynatronics Corp.
- SCALAR WAVE LASER SYSTEM by Stellar Lasers
- ST Applicator VRE2001 by VIORA LTD
- LUMIWAVE 1X4 INFRARED THERAPY DEVICE by Biocare Systems, Inc.
- AVANT LASER by AVANT WELLNESS SYSTEMS INC
- 810nm 200mW Dental Probe 2.3 by THOR PHOTOMEDICINE INC.
- BIOLIGHT PCD by Biolight International AB
- iLux LF D20 1LFD20 by MECTRONIC MEDICALE SRL
- IR Pro 250 by Lhasa Oms, Inc.