CaHA (Calcium hydroxylapatite)

This document is technical information about materials. It does not recommend any procedure or product.

In brief

A calcium phosphate ceramic used as a dermal biostimulatory material. The mineral phase is chemically identical to the inorganic component of bone.

Regulatory identity by market

KR MD
EU MD
US
JP
CN
VN

COS cosmetic · MD medical device · RX drug · — not established in public sources

Identity & physical properties
SynonymsCalcium hydroxylapatite, Calcium hydroxyapatite, CaHA
FormulaCa10(PO4)6(OH)2
FamilyBiostimulator — ceramic microsphere
Particle sizeReported in the tens of micrometres; a comparative morphology study places CaHA and PLLA particles side by side
MorphologySmooth spherical ceramic particles suspended in a carrier gel

Mechanism

Reviews describe particles acting as a scaffold with subsequent fibroblast response and matrix deposition. A systematic review has catalogued the reported skin-regeneration mechanisms.

Evidence

PMIDStudy typeSummary
37332763 review Skin regeneration-related mechanisms of CaHA: a systematic review
38853456 in vitro Morphological analysis of CaHA and PLLA biostimulator particles
37635437 review The role of CaHA as a regenerative aesthetic treatment: a narrative review

Regulatory identity — detail

MarketClassificationNoteBasis
KR medical-device Injectable forms follow the tissue-repair biomaterial route in the MFDS device classification notice. Legal text
EU medical-device Annex XVI, Section 3 of the MDR covers substances intended for facial or other dermal filling by injection, bringing such products under the Regulation even without an intended medical purpose. Legal text
US unclassified Product-level FDA classification not established from public sources as of the revision date below.
JP unclassified Not established from public sources as of the revision date below.
CN unclassified Not established from public sources as of the revision date below.
VN unclassified Not established from public sources as of the revision date below.

Limitations & open questions

Much of the evidence base is narrative or systematic review rather than head-to-head randomised comparison. Dilution and layer of placement vary widely in practice and are not standardised in the literature.

All statements on this page are drawn from the cited literature. Where a market’s regulatory classification could not be established from public sources, it is marked as not established rather than inferred.