PDLLA (Poly-D,L-lactic acid)
This document is technical information about materials. It does not recommend any procedure or product.
In brief
A synthetic biodegradable polyester used as a dermal biostimulatory material. Being racemic, it is amorphous rather than semi-crystalline, and hydrolyses to lactic acid monomers over time.
Regulatory identity by market
COS cosmetic · MD medical device · RX drug · — not established in public sources
Identity & physical properties
| Synonyms | Poly-D,L-lactic acid, Poly(D,L-lactide), PDLLA |
|---|---|
| Formula | (C3H4O2)n |
| Family | Biostimulator — aliphatic polyester |
| Particle size | Reported in the tens of micrometres for injectable microsphere forms; varies by manufacturer |
| Morphology | Amorphous microspheres (racemic, non-crystalline) |
Mechanism
Reported literature describes a foreign-body response to the polymer particles followed by fibroblast activity and extracellular matrix deposition. Animal work has reported associated angiogenesis and collagen synthesis in aged skin.
Evidence
Regulatory identity — detail
| Market | Classification | Note | Basis |
|---|---|---|---|
| KR | medical-device | Injectable forms follow the tissue-repair biomaterial route in the MFDS device classification notice. Topical formulations may fall under cosmetics, so classification depends on presentation. | 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 | FDA classification of standalone injectable PDLLA products 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
Most published work concerns injectable forms; findings do not transfer automatically to topical formulations. Particle specifications are not standardised across manufacturers, so figures reported in one study may not describe another product.
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.