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Biocompatibility and Hard Anodising

2005

We design and manufacture Laser Units destined for the cosmetic/aesthetic market.
The light energy is transmitted to the treated tissue by a "gun like" hand-piece, held by the Doctor. The tip of this hand piece comes in contact with the human skin.
The tip is made of Aluminum [6061-T6] with an Hard Anodise coating!
When applying for an FDA approval, we were requested to submit a letter of conformity regarding Biocompatibility of this coating.
I approached the coating companies [in Israel] but none of them could provide me with such a confirmation. The only compliance they could provide was to MIL-A-8625 / MIL-PRF-8625 [on DLA] -Type III !
Basically it looks simple - Hard Anodise means - Aluminum Oxide [Al2O3] means - "ceramics" which is a well known implant material, for example.
Anybody has any relevant information regarding this issue.

Yoav Avni
- Caesarea, Israel

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